Trial Outcomes & Findings for Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma (NCT NCT02879318)
NCT ID: NCT02879318
Last Updated: 2025-03-24
Results Overview
Time from randomization to death from any cause with patients who were alive at the time of the final analysis or who became lost to follow-up censored at their last date known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
35 months
Results posted on
2025-03-24
Participant Flow
From April 10, 2017 to July 28, 2018 in 25 cancer centres in Canada
There was a run-in phase of this study which accrued the first patient on August 22, 2016, which can be considered as start date of this study. Only patients recruited from April 10, 2017 to July 28, 2018 into the randomized phase II component of the study were included in the analysis.
Participant milestones
| Measure |
Gemcitabine Plus Nab-Paclitaxel
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
119
|
|
Overall Study
COMPLETED
|
61
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Gemcitabine Plus Nab-Paclitaxel
n=61 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
n=119 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
64 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Age, Customized
Younger than 65 years
|
27 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Age, Customized
65 years or older
|
34 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 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
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
160 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
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
61 participants
n=99 Participants
|
119 participants
n=107 Participants
|
180 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
47 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 35 monthsTime from randomization to death from any cause with patients who were alive at the time of the final analysis or who became lost to follow-up censored at their last date known to be alive.
Outcome measures
| Measure |
Gemcitabine Plus Nab-Paclitaxel
n=61 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
n=119 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
|---|---|---|
|
Overall Survival
|
8.8 months
Interval 7.2 to 11.2
|
9.8 months
Interval 8.3 to 12.2
|
SECONDARY outcome
Timeframe: 35 monthsDefined as the time from randomization to the first objective documentation of disease progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death due to any cause with patients who had not progressed or died at the time of final analysis censored on the date of the last tumour assessment.
Outcome measures
| Measure |
Gemcitabine Plus Nab-Paclitaxel
n=61 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
n=119 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
|---|---|---|
|
Progression Free Survival
|
5.4 months
Interval 3.6 to 6.6
|
5.5 months
Interval 3.8 to 5.7
|
SECONDARY outcome
Timeframe: 35 monthsDefined as percentage of participants with objective response over all participants randomized. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine Plus Nab-Paclitaxel
n=61 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
n=119 Participants
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
|---|---|---|
|
Objective Response Rate
Not responded
|
47 Participants
|
83 Participants
|
|
Objective Response Rate
Responded
|
14 Participants
|
36 Participants
|
Adverse Events
Gemcitabine Plus Nab-Paclitaxel
Serious events: 26 serious events
Other events: 57 other events
Deaths: 52 deaths
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
Serious events: 82 serious events
Other events: 118 other events
Deaths: 102 deaths
Serious adverse events
| Measure |
Gemcitabine Plus Nab-Paclitaxel
n=58 participants at risk
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
n=119 participants at risk
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Cardiac disorders
Heart failure
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
6/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
2.5%
3/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Pancreatic duct stenosis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Chills
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Death NOS
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Edema limbs
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
2.5%
3/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Edema trunk
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Fatigue
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Fever
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
11.8%
14/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Sudden death NOS
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Immune system disorders
Other immune system disorders
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
6.7%
8/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Biliary tract infection
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
8.4%
10/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Catheter related infection
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
2.5%
3/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Lung infection
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Other infections and infestations
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Sepsis
|
12.1%
7/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.1%
12/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Skin infection
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
3.4%
4/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Stroke
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
2.5%
3/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Confusion
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
2.5%
3/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
1.7%
2/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
3.4%
4/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Hypotension
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
3.4%
4/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Other vascular disorders
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Thromboembolic event
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
Other adverse events
| Measure |
Gemcitabine Plus Nab-Paclitaxel
n=58 participants at risk
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Gemcitabine
Nab-paclitaxel
|
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab
n=119 participants at risk
Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days.
plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine
Nab-paclitaxel
Durvalumab
Tremelimumab
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
6.7%
8/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.1%
12/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
70.7%
41/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
73.9%
88/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Stomach pain
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.1%
12/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
48.3%
28/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
50.4%
60/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Chills
|
10.3%
6/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
16.0%
19/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Edema face
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Edema limbs
|
43.1%
25/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
47.9%
57/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Fatigue
|
82.8%
48/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
86.6%
103/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Fever
|
31.0%
18/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
40.3%
48/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Flu like symptoms
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
12.6%
15/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
16.0%
19/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
General disorders
Pain
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
9.2%
11/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Lung infection
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.1%
12/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Skin infection
|
13.8%
8/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
13.4%
16/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
12.1%
7/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
3.4%
4/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.84%
1/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Investigations
Weight loss
|
29.3%
17/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
26.1%
31/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.3%
35/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
63.9%
76/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
6/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
12.6%
15/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
6/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
23.5%
28/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
39.7%
23/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
52.1%
62/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.1%
7/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
13.4%
16/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
14.3%
17/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.1%
7/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
22.7%
27/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Dizziness
|
15.5%
9/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
20.2%
24/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
27.6%
16/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
28.6%
34/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Headache
|
22.4%
13/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
21.8%
26/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Paresthesia
|
12.1%
7/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
14.3%
17/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.3%
6/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
34.5%
20/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
49.6%
59/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Anxiety
|
15.5%
9/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
27.7%
33/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Confusion
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
6.7%
8/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Depression
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
14.3%
17/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Insomnia
|
29.3%
17/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
44.5%
53/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Psychiatric disorders
Libido decreased
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
0.00%
0/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.1%
12/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.1%
14/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
29.4%
35/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
9.2%
11/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.3%
28/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
53.8%
64/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
14.3%
17/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.9%
13/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
6.7%
8/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.9%
22/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
47.1%
56/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.7%
12/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
18.5%
22/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
6/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
24.4%
29/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
12.6%
15/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.1%
14/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
42.9%
51/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Hot flashes
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Hypertension
|
12.1%
7/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
9.2%
11/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Hypotension
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Vascular disorders
Thromboembolic event
|
29.3%
17/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
25.2%
30/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
8.4%
10/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.2%
10/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
14.3%
17/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
2.5%
3/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Eye disorders
Blurred vision
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
10.1%
12/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Eye disorders
Dry eye
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.9%
7/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
4/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
8.4%
10/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
77.6%
45/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
78.2%
93/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Ascites
|
5.2%
3/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
4.2%
5/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Bloating
|
3.4%
2/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
11.8%
14/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
56.9%
33/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
67.2%
80/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
56.9%
33/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
63.9%
76/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
5/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
7.6%
9/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.5%
9/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
16.8%
20/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/58 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
5.0%
6/119 • 35 months
Only patients who received at least one dose of protocol treatment were included in the evaluation of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place