Metastatic Pancreatic Cancer
Conditions
Brief summary
Phase III Metastatic Pancreatic Cancer
Detailed description
A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.
Interventions
DRUGAlbumin-bound paclitaxel (ABI-007)
ABI-007 125 mg/m\^2 administered by intravenous infusion
DRUGGemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
A participant will be eligible for inclusion in this study only if all of the following criteria are met: 1. Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded. 2. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to randomization in the study. 3. Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media). 4. Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual. 5. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study. 6. Patient has adequate biological parameters as demonstrated by the following blood counts at Baseline (obtained ≤14 days prior to randomization): Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count ≥ 100,000/mm\^3 (100 × 10\^9/L); Hemoglobin (Hgb) ≥ 9 g/dL. 7. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization): Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed Total bilirubin ≤ ULN Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) \>30 kg/m\^2, lean body weight should be used instead. 8. Patient has acceptable coagulation studies (obtained ≤14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (± 15%). 9. Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to randomization). 10. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true. 11. Patients should be asymptomatic for jaundice prior to Day 1. Significant or symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1. 12. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Exclusion criteria
A patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart). 2. Patient has only locally advanced disease. 3. Patient has experienced a ≥10% decrease in KPS between baseline visit and within 72 hours prior to randomization. 4. Patient has a ≥20% decrease in serum albumin level between baseline visit and within 72 hours prior to randomization. 5. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years. 6. Patient uses Coumadin. 7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 8. Patient has known historical or active infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C. 9. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study. 10. Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics (SmPC) or Prescribing Information. 11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa). 12. Patients with a history of interstitial lung disease. 13. History of chronic leukemias (e.g., chronic lymphocytic leukemia). 14. Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year. 15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease). 16. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity. 17. Patient is enrolled in any other clinical protocol or investigational trial. 18. Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. | Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) by Independent Radiological Review (IRR) | Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. | Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods. |
| Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months | Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment Emergent Adverse Events (AE) | Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days | A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. |
| Number of Participants With Dose Delays/Doses Not Given | Up to 666 days | The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy. |
| Number of Participants With Dose Reductions | Maximum time on treatment was 666 days | The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. |
| Number of Participants With Dose Interruptions | Maximum time on treatment was 666 days | The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Italy, Russia, Spain, Ukraine, United States
Participant flow
Recruitment details
Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)
Pre-assignment details
38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)
Participants by arm
| Arm | Count |
|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine ABI-007 125 mg/m\^2 administered in combination with gemcitabine 1000 mg/m\^2 weekly for 3 weeks followed by one week of rest.
Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m\^2 administered in combination with Gemcitabine 1000 mg/m\^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest | 431 |
| Gemcitabine Gemcitabine, 1000 mg/m\^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward). | 430 |
| Total | 861 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 128 | 73 |
| Overall Study | Other | 7 | 10 |
| Overall Study | Physician Decision | 25 | 18 |
| Overall Study | Progressive Disease | 196 | 245 |
| Overall Study | Protocol Violation | 10 | 6 |
| Overall Study | Withdrawal by Subject | 28 | 39 |
| Overall Study | Withdrew prior to starting treatment | 11 | 27 |
Baseline characteristics
| Characteristic | Gemcitabine | Total | Albumin-bound Paclitaxel (ABI-007)/Gemcitabine |
|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 9.27 | 62.2 years STANDARD_DEVIATION 10.04 | 61.4 years STANDARD_DEVIATION 10.7 |
| Karnofsky Performance Status (KPS) 0% = Dead | 0 participants | 0 participants | 0 participants |
| Karnofsky Performance Status (KPS) 100% = normal, no complaints, no signs of disease | 69 participants | 138 participants | 69 participants |
| Karnofsky Performance Status (KPS) 10% = Moribund, fatal processes progressing fast | 0 participants | 0 participants | 0 participants |
| Karnofsky Performance Status (KPS) 20% = hospitalized; requires supportive treatment | 0 participants | 0 participants | 0 participants |
| Karnofsky Performance Status (KPS) 30% = severely disabled; death is imminent | 0 participants | 0 participants | 0 participants |
| Karnofsky Performance Status (KPS) 40% = disabled; requires special care & assistance | 0 participants | 0 participants | 0 participants |
| Karnofsky Performance Status (KPS) 50% = needs help often and medical care | 0 participants | 0 participants | 0 participants |
| Karnofsky Performance Status (KPS) 60% = needs help, can manage most tasks | 0 participants | 2 participants | 2 participants |
| Karnofsky Performance Status (KPS) 70% = caring for self, unable to work | 33 participants | 63 participants | 30 participants |
| Karnofsky Performance Status (KPS) 80% = normal activity, some symptoms of disease | 128 participants | 277 participants | 149 participants |
| Karnofsky Performance Status (KPS) 90% = normal activity, few symptoms of disease | 199 participants | 378 participants | 179 participants |
| Number of Baseline Lesions (Target + Non-Target) 1 | 0 participants | 1 participants | 1 participants |
| Number of Baseline Lesions (Target + Non-Target) 2 | 25 participants | 57 participants | 32 participants |
| Number of Baseline Lesions (Target + Non-Target) 3 | 7 participants | 14 participants | 7 participants |
| Number of Baseline Lesions (Target + Non-Target) 4 | 43 participants | 80 participants | 37 participants |
| Number of Baseline Lesions (Target + Non-Target) 5 | 8 participants | 16 participants | 8 participants |
| Number of Baseline Lesions (Target + Non-Target) >5 | 262 participants | 538 participants | 276 participants |
| Pancreatic Primary Tumor Location Body | 136 participants | 268 participants | 132 participants |
| Pancreatic Primary Tumor Location Head | 180 participants | 371 participants | 191 participants |
| Pancreatic Primary Tumor Location Tail | 110 participants | 215 participants | 105 participants |
| Pancreatic Primary Tumor Location Unknown = not specified | 4 participants | 7 participants | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 32 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 26 Participants | 51 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 375 Participants | 753 Participants | 378 Participants |
| Sex: Female, Male Female | 173 Participants | 359 Participants | 186 Participants |
| Sex: Female, Male Male | 257 Participants | 502 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 412 / 421 | 392 / 402 |
| serious Total, serious adverse events | 212 / 421 | 172 / 402 |
Outcome results
Primary
Overall Survival (OS)
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
Time frame: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Population: Intent to Treat population (ITT population) consisted of all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Overall Survival (OS) | 8.5 months |
| Gemcitabine | Overall Survival (OS) | 6.7 months |
p-value: <0.000195% CI: [0.617, 0.835]Stratified Log-rank Test
Secondary
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Time frame: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Population: Intent to Treat population (ITT population) consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | 23 percentage of participants |
| Gemcitabine | Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) | 7 percentage of participants |
Comparison: PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.p-value: <0.000195% CI: [2.178, 4.662]Chi-squared
Secondary
Progression-free Survival (PFS) by Independent Radiological Review (IRR)
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
Time frame: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Population: Intent to Treat population (ITT population) consisted of all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Progression-free Survival (PFS) by Independent Radiological Review (IRR) | 5.5 months |
| Gemcitabine | Progression-free Survival (PFS) by Independent Radiological Review (IRR) | 3.7 months |
p-value: <0.000195% CI: [0.581, 0.821]Stratified Log-rank Test
Other Pre-specified
Number of Participants With Dose Delays/Doses Not Given
The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.
Time frame: Up to 666 days
Population: Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Number of Participants With Dose Delays/Doses Not Given | At least 1 ABI-007 dose delay/Not given | 300 number of dose delays |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Number of Participants With Dose Delays/Doses Not Given | At least ≥ 1 Gem dose delay/Not given | 295 number of dose delays |
| Gemcitabine | Number of Participants With Dose Delays/Doses Not Given | At least 1 ABI-007 dose delay/Not given | 0 number of dose delays |
| Gemcitabine | Number of Participants With Dose Delays/Doses Not Given | At least ≥ 1 Gem dose delay/Not given | 230 number of dose delays |
Other Pre-specified
Number of Participants With Dose Interruptions
The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time frame: Maximum time on treatment was 666 days
Population: Safety population, includes participants who received at least one study treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Number of Participants With Dose Interruptions | ≥ 1 Albumin-bound paclitaxel dose interruption | 2 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Number of Participants With Dose Interruptions | At least 1 Gemcitabine dose interruption | 8 participants |
| Gemcitabine | Number of Participants With Dose Interruptions | ≥ 1 Albumin-bound paclitaxel dose interruption | 0 participants |
| Gemcitabine | Number of Participants With Dose Interruptions | At least 1 Gemcitabine dose interruption | 9 participants |
Other Pre-specified
Number of Participants With Dose Reductions
The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Time frame: Maximum time on treatment was 666 days
Population: Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Number of Participants With Dose Reductions | At least 1 alumbin bound paclitaxel dose reduction | 172 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Number of Participants With Dose Reductions | At least 1 Gemcitabine dose reduction | 198 participants |
| Gemcitabine | Number of Participants With Dose Reductions | At least 1 alumbin bound paclitaxel dose reduction | 0 participants |
| Gemcitabine | Number of Participants With Dose Reductions | At least 1 Gemcitabine dose reduction | 132 participants |
Other Pre-specified
Participants With Treatment Emergent Adverse Events (AE)
A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.
Time frame: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
Population: Treated patient population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 treatment related SAE | 121 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE leading to stopping treatment | 149 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | At least 1 Serious Adverse Event (SAE) | 212 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE leading to death | 18 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 Grade (GR) 3/4 AE | 370 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE leading to dose reduction of ABI-007 or Gem | 209 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 Treatment related AE (TEAE) | 403 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE related dose interruption of ABI-007 or Gem | 11 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 Grade 3 or higher AE | 374 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE related dose delay of ABI-007 or Gem | 276 participants |
| Albumin-bound Paclitaxel (ABI-007)/Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | At least 1 AE | 417 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE related dose delay of ABI-007 or Gem | 192 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | At least 1 AE | 395 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 Treatment related AE (TEAE) | 371 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | At least 1 Serious Adverse Event (SAE) | 172 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 treatment related SAE | 53 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 Grade (GR) 3/4 AE | 298 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 Grade 3 or higher AE | 303 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE leading to stopping treatment | 95 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE leading to death | 18 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE leading to dose reduction of ABI-007 or Gem | 125 participants |
| Gemcitabine | Participants With Treatment Emergent Adverse Events (AE) | ≥ 1 AE related dose interruption of ABI-007 or Gem | 10 participants |