Quality of Life in Locally Advanced or Metastatic Pancrea... | NCT02106884

NCT02106884

ID	Type	Description	Link
2013-004101-75	EudraCT Number
AX-CL-PANC-PI-003568	Other Grant/Funding Number	Celgene

Status Module

Sponsor/Collaborators Module

Name	Class
Celgene Corporation	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks	Drug: Nab-paclitaxel Drug: Gemcitabine
Arm B	Active Comparator	Gemcitabine - IV - 1000 mg/m2 - 3xq4wks	Drug: Gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
Nab-paclitaxel	Drug		Arm A	Abraxane, EU/1/07/428/001, L01CD01
Gemcitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)	The QOL global health status (GHS) is a functional parameter derived from the EORTC QLQ - C30 questionnaire, based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?". Transformed scores range from 0 to 100% with higher scores representing better outcomes. The deterioration free survival rate at 3 mos is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL score at 3 mos. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to baseline, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after deterioration. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.	From date of randomisation to 3, 6 and 12 months respectively
QOL Global Health Status Deterioration-free Median Survival	The deterioration-free survival is defined as the Kaplan-Meier estimate of median survival time to definitive deterioration of the QOL score or death. See primary outcome 1 for scale description. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to the baseline score, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after the deterioration was observed. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.	From date of randomisation to end of follow up (max 3 years after database lock when applicable).

Secondary Outcomes

Measure	Description	Time Frame
Overall Response	Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response (OR) is defined as the best tumor response on treatment for each patient. Responders were considered CR + PR. Some patients were not evaluable for response (no scans available). Overall response rates (ORR) were calculated based on the ITT set.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/local regulations.
Patient is at least 18 years of age .
Unresectable locally advanced or metastatic pancreatic cancer.
Histologically or cytologically confirmed adenocarcinoma of the pancreas. Islet cell neoplasms are excluded.
Evaluable or measurable disease, not in a previously irradiated area.
Life expectancy of at least 12 weeks.
WHO ECOG performance status ≤ 2
Adequate organ function.
Adequate bone marrow, hepatic and renal function. Acceptable coagulation (prothrombin time and partial thromboplastin time within +/- 15% of normal limits).
No clinically significant abnormalities in urinalysis.
Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.

Exclusion criteria:

Prior chemotherapy, radiotherapy, surgery or other investigational therapy for the treatment for metastatic disease. Adjuvant treatment with gemcitabine or 5-FU is allowed provided at least 6 months have elapsed since completion of the last dose.
Major surgery within 4 weeks of the start of the study.
Irradiation within 3 weeks prior to study entry.
Brain metastasis (known or suspected).
Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk including coronary stenting or myocardial infarction in the last year and psychiatric disorders.
Historical or active infection with HIV, hepatitis B or C.
History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa, etc).
History of interstitial lung disease.
History of peripheral artery disease.
Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
Known allergy or any other adverse reaction to any of the drugs or to any related compound.
Use of Coumadin.
Organ allografts requiring immunosuppressive therapy.
Pregnancy or breast-feeding.
Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.

Contacts/Locations Module

Name	Affiliation	Role
Eric Van Cutsem, MD	UZ Leuven	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
OLV Ziekenhuis Aalst		Aalst		9300	Belgium
AZ Klina

References Module

Label	URL
The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.	View source
Quality-of-life (QoL) as a predictive biomarker in patients with advanced pancreatic cancer (APC) receiving chemotherapy: results from a prospective multicenter phase 2 trial.	View source

ID	Title	Description
FG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 8, 2015

Categories

Rate at 3 months (percentage)

Title	Measurements
	OG00089 OG00173

Rate at 6 months (percentage)

Title	Measurements
	OG000

Primary

QOL Global Health Status Deterioration-free Median Survival

The deterioration-free survival is defined as the Kaplan-Meier estimate of median survival time to definitive deterioration of the QOL score or death. See primary outcome 1 for scale description. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to the baseline score, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after the deterioration was observed. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.

Posted

Median

95% Confidence Interval

Months

From date of randomisation to end of follow up (max 3 years after database lock when applicable).

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel +Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.

Secondary

Overall Response

Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response (OR) is defined as the best tumor response on treatment for each patient. Responders were considered CR + PR. Some patients were not evaluable for response (no scans available). Overall response rates (ORR) were calculated based on the ITT set.

Posted

Count of Participants

Participants

Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.

Secondary

Duration of Response (in Responders)

Duration of response was calculated from the date of first documented response to the date of progression (including SD after PR) or date of start of new treatment in not progressed, when available. In 2 patients with CR, periods of PR are included. For those not documented as progressed before death, an unknown duration was kept and considered missing data.

Posted

Median

95% Confidence Interval

Months

Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.

Secondary

Disease Control

Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response is defined as the best tumor response on treatment for each patient. Disease control is defined as a best response on treatment of either CR, PR or SD (CR + PR + SD). Some patients were not evaluable for response (no scans available). Overall response rates were calculated based on the ITT set.

Posted

Count of Participants

Participants

Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel) - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.

Secondary

Progression Free Survival

Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT).

Posted

Median

95% Confidence Interval

Months

Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
OG001	Arm B (Gemcitabine)

Secondary

Overall Survival

Overall survival was considered from start of treatment to death. All patients (ITT)

Posted

Median

95% Confidence Interval

Months

Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
OG001	Arm B (Gemcitabine)	Patients were randomised to receive gemcitabine monotherapy. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination.

Secondary

Laboratory Safety Assessment

Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set).

All pts treated (safety set). Analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses in treatment switchers will be published in a peer reviewed journal.

Posted

Count of Participants

Participants

Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient.

ID	Title	Description
OG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel) - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
OG001	Arm B (Gemcitabine)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks	5	72	50	72	72	72
EG001	Arm B (Gemcitabine)	Gemcitabine - IV - 1000 mg/m2 - 3xq4wks	11	74	48	74	74	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thromboembolic event	Vascular disorders	NCI -CTCAE V4	Systematic Assessment	EG0005 events3 affected72 at risk EG0013 events3 affected74 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Edema limbs	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Fatigue	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0015 events5 affected74 at risk
Fever	General disorders	NCI -CTCAE V4	Systematic Assessment	EG00010 events9 affected72 at risk EG00110 events9 affected74 at risk
Flu like symptoms	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Malaise	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0011 events1 affected74 at risk
Multi-organ failure	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Alteration of general condition	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Drug misuse	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Generalized edema	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Pain	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Galbladder obstruction	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Confusion	Psychiatric disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Fall	Injury, poisoning and procedural complications	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Fracture	Injury, poisoning and procedural complications	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Neutrophil count decreased	Investigations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Platelet count decreased	Investigations	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Myocardial infarction	Cardiac disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0010 events0 affected74 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Anemia	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0013 events3 affected74 at risk
Febrile neutropenia	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Hemolytic Uremic Syndrome	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0012 events2 affected74 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Ischemia cerebrovascular	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Tremor	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Vasovagal reaction	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Vertigo	Ear and labyrinth disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Abdominal pain	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0014 events4 affected74 at risk
Ascites	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Colonic perforation	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Constipation	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0010 events0 affected74 at risk
Diarrhea	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0010 events0 affected74 at risk
Duodenal and galbladder obstruction on stent	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Duodenal obstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Gastric hemorrhage	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Gastric ulcer	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Nausea	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected74 at risk
Obstruction gastric	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Colitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Diverticulitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Gastro-enteritis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Sigmoiditis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Pancreatic duct stenosis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Pancreatitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0012 events2 affected74 at risk
Small intestinal obstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0012 events1 affected74 at risk
Stomach pain	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Vomiting	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0013 events3 affected74 at risk
Acute kidney injury	Renal and urinary disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0014 events3 affected74 at risk
Bile duct stenosis	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0014 events3 affected74 at risk
Cholecystitis	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0013 events2 affected74 at risk
Cholangitis	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Cholestasis	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Jaundice	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected74 at risk
Appendicitis	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Back pain	Musculoskeletal and connective tissue disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0010 events0 affected74 at risk
Hyperthyroidism	Endocrine disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Anorexia	Metabolism and nutrition disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events2 affected72 at risk EG0014 events3 affected74 at risk
Major denutrition	Metabolism and nutrition disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Abdominal infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0002 events1 affected72 at risk EG0010 events0 affected74 at risk
Biliary tract infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0013 events3 affected74 at risk
Bladder infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Bronchial infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Hepatic infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0002 events1 affected72 at risk EG0010 events0 affected74 at risk
Lung infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0009 events7 affected72 at risk EG0012 events2 affected74 at risk
Infectious syndrome	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Infectious exacerbation of chronic obstructive airways disease	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Septic thromboflebitis	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Sepsis	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Urinary tract infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0004 events4 affected72 at risk EG0010 events0 affected74 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Capillary leak syndrome	Vascular disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Hematoma	Vascular disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Hypertension	Vascular disorders	NCI -CTCAE V4	Systematic Assessment	EG00012 events8 affected72 at risk EG00111 events7 affected74 at risk
Thromboembolic event	Vascular disorders	NCI -CTCAE V4	Systematic Assessment	EG0006 events5 affected72 at risk EG0018 events6 affected74 at risk
Hypotension	Vascular disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Edema limbs	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected74 at risk
Fatigue	General disorders	NCI -CTCAE V4	Systematic Assessment	EG00026 events16 affected72 at risk EG00138 events21 affected74 at risk
Fever	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Multi-organ failure	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
General status altteration	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0013 events3 affected74 at risk
Pain	General disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events1 affected72 at risk EG0015 events5 affected74 at risk
Agitation	Psychiatric disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Anxiety	Psychiatric disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Depression	Psychiatric disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Insomnia	Psychiatric disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Fall	Injury, poisoning and procedural complications	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Weight loss	Investigations	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0012 events2 affected74 at risk
Cardiac arrest	Cardiac disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Myocardial infarction	Cardiac disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0013 events3 affected74 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0009 events6 affected72 at risk EG0015 events4 affected74 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
COPD	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Anemia	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0009 events7 affected72 at risk EG00118 events11 affected74 at risk
Febrile neutropenia	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0004 events3 affected72 at risk EG0010 events0 affected74 at risk
Hemolytic uremic syndrome	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events3 affected72 at risk EG0013 events3 affected74 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Headache	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Hemiparesis	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Peripheral sensory neuropathy	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0006 events5 affected72 at risk EG0013 events2 affected74 at risk
Peripheral motor neuropathy	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0003 events2 affected72 at risk EG0010 events0 affected74 at risk
Somnolence	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Syncope	Nervous system disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0013 events3 affected74 at risk
Abdominal pain	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0005 events3 affected72 at risk EG0019 events8 affected74 at risk
Ascites	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Colitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Colinic obstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events1 affected74 at risk
Constipation	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Diarrhea	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0005 events5 affected72 at risk EG0012 events2 affected74 at risk
Gastric ulcer	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Gastroparesis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Gastrointestinal pain	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Ileus	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Mucositis oral	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0010 events0 affected74 at risk
Nausea	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0005 events5 affected72 at risk EG0016 events6 affected74 at risk
Obstruction gastric	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected74 at risk
Diverticulitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Intrapancreatic obstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Hematemesis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Hernia inguinalis with obstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Pancreatitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0012 events2 affected74 at risk
Small intestinal onstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0013 events2 affected74 at risk
Stomach pain	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Upper GI haemorrhage	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Vomiting	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0006 events6 affected72 at risk EG0014 events4 affected74 at risk
Colonic perforation	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Acute kidney injury	Renal and urinary disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0013 events3 affected74 at risk
Bile duct stenosis	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0016 events6 affected74 at risk
Cholecystitis	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0016 events4 affected74 at risk
Galbladder obstruction	Gastrointestinal disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Hepatic failure	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0011 events1 affected74 at risk
Cholestasis	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0013 events2 affected74 at risk
Dilated bile ducts	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Jaundice	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0010 events0 affected74 at risk
Back pain	Musculoskeletal and connective tissue disorders	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0012 events2 affected74 at risk
Bone pain	Musculoskeletal and connective tissue disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Myalgia	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events1 affected72 at risk EG0010 events0 affected74 at risk
Pain in extremity	Hepatobiliary disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Hypothyroidism	Endocrine disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Anorexia	Metabolism and nutrition disorders	NCI -CTCAE V4	Systematic Assessment	EG0008 events7 affected72 at risk EG00118 events14 affected74 at risk
Dehydration	Metabolism and nutrition disorders	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected74 at risk
Abdominal infection	Metabolism and nutrition disorders	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected74 at risk
Appendicitis	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Biliary tract infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected74 at risk
Bladder infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Bronchial infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Catheter related infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Galbladder infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0002 events1 affected72 at risk EG0010 events0 affected74 at risk
Hepatic infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0002 events1 affected72 at risk EG0012 events1 affected74 at risk
Lung infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0007 events6 affected72 at risk EG0013 events3 affected74 at risk
Infection without neutropenia NOS	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Paronychia	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Pleural infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected74 at risk
Sepsis	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0002 events2 affected72 at risk EG0012 events2 affected74 at risk
Tooth infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected74 at risk
Urinary tract infection	Infections and infestations	NCI -CTCAE V4	Systematic Assessment	EG0004 events4 affected72 at risk EG0010 events0 affected74 at risk

Quality of life endpoints are sensitive to confounding factors such as age, intercurrent disease, time from last completed questionnaire to the last follow-up or death. Tumour response and AE relationship to treatment were locally adressed.

Certain Agreements

ID	Term
D010190	Pancreatic Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ParticipantsBG002146

ID	Title	Description
BG000	Arm A (Nab-Paclitaxel + Gemcitabine)	Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine. Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
BG001	Arm B (Gemcitabine Monotherapy)	Patients were randomised to receive gemcitabine monotherapy. Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination.
BG002	Total	Total of all reporting groups