Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer (NCT NCT03941093)
NCT ID: NCT03941093
Last Updated: 2024-11-05
Results Overview
Overall survival was defined as the time from date of randomization to date of death due to any cause. Overall survival was calculated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
284 participants
Primary outcome timeframe
Up to approximately 5 years
Results posted on
2024-11-05
Participant Flow
Participants were randomized in a 1:1 ratio to one of the 2 study treatment arms: Pamrevlumab with Gemcitabine/Nab-paclitaxel or FOLFIRINOX or Placebo with Gemcitabine/Nab-paclitaxel or FOLFIRINOX.
Participant milestones
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via intravenous (IV) infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
141
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
142
|
141
|
|
Overall Study
COMPLETED
|
134
|
134
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via intravenous (IV) infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
Baseline Characteristics
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=143 Participants
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 Participants
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 9.54 • n=99 Participants
|
64.5 years
STANDARD_DEVIATION 9.60 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 9.56 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 5 yearsPopulation: The ITT population included all randomized participants regardless of whether or not study treatment was received.
Overall survival was defined as the time from date of randomization to date of death due to any cause. Overall survival was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=143 Participants
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 Participants
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Overall Survival
|
17.25 months
Interval 15.47 to 18.89
|
17.94 months
Interval 14.59 to 20.34
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsPopulation: The ITT population included all randomized participants regardless of whether or not study treatment was received.
The EFS endpoint was a composite time-to-event endpoint. The event being analyzed ('treatment failure') was defined as the earliest occurrence of: a) failure to achieve disease-free status locally after completion of neoadjuvant treatment and/or after surgery (that is, resection failure or progression that precludes surgery); b) local or distant recurrence, or c) death. The EFS was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=143 Participants
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 Participants
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Event-free Survival (EFS)
|
5.72 months
Interval 5.59 to 6.01
|
5.78 months
Interval 5.62 to 6.37
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsPopulation: The ITT population included all randomized participants regardless of whether or not study treatment was received.
The PFS was defined as time from date of randomization until disease progression or death due to any cause, whichever occurred first. PFS was calculated using the Kaplan-Meier method. Progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions and the appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=143 Participants
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 Participants
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
9.36 months
Interval 7.75 to 11.79
|
9.40 months
Interval 7.69 to 10.84
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsPopulation: The ITT population included all randomized participants regardless of whether or not study treatment was received.
Best overall objective response was defined as a complete response (CR) or partial response (PR). CR was defined as disappearance of all target or non-target lesions and normalization of tumor marker level (for non-target lesions), any pathological lymph nodes (whether target or non-target) must have reduced in short axis to \<10 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 |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=143 Participants
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 Participants
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1
|
43 Participants
|
64 Participants
|
Adverse Events
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
Serious events: 75 serious events
Other events: 139 other events
Deaths: 118 deaths
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
Serious events: 62 serious events
Other events: 140 other events
Deaths: 112 deaths
Serious adverse events
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=142 participants at risk
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 participants at risk
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.1%
3/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Colitis
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.1%
3/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.8%
4/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Pyrexia
|
3.5%
5/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Asthenia
|
2.1%
3/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Death
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Hypothermia
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Oedema peripheral
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
4.9%
7/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
5.7%
8/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Biliary obstruction
|
2.1%
3/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
3.5%
5/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Malignant biliary obstruction
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Sepsis
|
4.9%
7/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Pneumonia
|
3.5%
5/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.8%
4/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Liver abscess
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.1%
3/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Bacteraemia
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Catheter site infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Cholangitis infective
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Cholecystitis infective
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.1%
3/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Post procedural infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Septic shock
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Tongue fungal infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Neutrophil count decreased
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Platelet count decreased
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
3/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Syncope
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Product Issues
Device occlusion
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Renal and urinary disorders
Renal injury
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
3/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.4%
2/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Pseudocellulitis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Hypotension
|
0.70%
1/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.00%
0/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
1.4%
2/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
0.71%
1/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
Other adverse events
| Measure |
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=142 participants at risk
Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX
n=141 participants at risk
Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil.
|
|---|---|---|
|
General disorders
Fatigue
|
59.2%
84/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
53.9%
76/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
57.0%
81/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
63.8%
90/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
47.9%
68/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
51.8%
73/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
38.0%
54/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
47.5%
67/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.3%
53/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
40.4%
57/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Neutrophil count decreased
|
35.9%
51/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
39.7%
56/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.2%
50/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
34.0%
48/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Oedema peripheral
|
31.0%
44/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
36.9%
52/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Constipation
|
26.8%
38/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
27.7%
39/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
38/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
28.4%
40/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Platelet count decreased
|
25.4%
36/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
30.5%
43/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.9%
34/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
25.5%
36/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.8%
31/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
21.3%
30/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
21.1%
30/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
18.4%
26/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Pyrexia
|
21.1%
30/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
21.3%
30/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Asthenia
|
19.0%
27/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
19.1%
27/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
17.6%
25/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
17.7%
25/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
White blood cell count decreased
|
16.9%
24/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
19.9%
28/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Dysgeusia
|
16.2%
23/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
18.4%
26/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.2%
23/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
20.6%
29/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Alanine aminotransferase increased
|
13.4%
19/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
13.5%
19/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Weight decreased
|
13.4%
19/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.8%
18/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.7%
18/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
23.4%
33/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.7%
18/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
7.8%
11/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.7%
18/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
16.3%
23/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
17/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
8.5%
12/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
17/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.8%
18/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Paraesthesia
|
12.0%
17/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.8%
18/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.3%
16/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
10.6%
15/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Hypotension
|
11.3%
16/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
9.2%
13/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Psychiatric disorders
Insomnia
|
11.3%
16/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
14.2%
20/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Headache
|
10.6%
15/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.8%
18/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
14/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.8%
18/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.9%
14/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.9%
14/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.1%
17/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.2%
13/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
7.1%
10/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
13/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.1%
17/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.5%
12/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
9.9%
14/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.5%
12/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
8.5%
12/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
11/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Chills
|
7.0%
10/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
7.8%
11/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
10/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
14.9%
21/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
10/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
10/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
5.0%
7/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Blood creatinine increased
|
6.3%
9/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.8%
4/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
9/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
5.7%
8/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Nervous system disorders
Dizziness
|
6.3%
9/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
15.6%
22/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.3%
9/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.3%
9/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
2.8%
4/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.3%
9/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
6.4%
9/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.6%
8/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
6.4%
9/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
8/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
4.3%
6/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
8/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
3.5%
5/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.9%
7/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
7.1%
10/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.9%
7/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
9.9%
14/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Psychiatric disorders
Anxiety
|
4.2%
6/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
7.1%
10/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.2%
6/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
11.3%
16/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
6/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
9.9%
14/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Vascular disorders
Hypertension
|
3.5%
5/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
5.7%
8/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Investigations
Lymphocyte count decreased
|
3.5%
5/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
12.8%
18/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Psychiatric disorders
Depression
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
5.7%
8/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
General disorders
Influenza like illness
|
2.8%
4/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
5.7%
8/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
|
Renal and urinary disorders
Dysuria
|
2.1%
3/142 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
7.1%
10/141 • Up to approximately 5 years
Per planned analysis all-cause mortality data were collected and reported for all randomized participants. Adverse events (serious and other) were collected and reported for all randomized participants who received study drug.
|
Additional Information
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