Trial Outcomes & Findings for EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX (NCT NCT03126435)
NCT ID: NCT03126435
Last Updated: 2023-05-06
Results Overview
The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)
Results posted on
2023-05-06
Participant Flow
218 subjects were enrolled between October 2018 and July 2020.
Participant milestones
| Measure |
EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
110
|
|
Overall Study
COMPLETED
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
106
|
104
|
Reasons for withdrawal
| Measure |
EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Overall Study
Death
|
90
|
84
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
12
|
|
Overall Study
e.g. Sponsor Decision, General Deterioration...
|
6
|
4
|
Baseline Characteristics
EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
Baseline characteristics by cohort
| Measure |
EndoTAG-1 and Gemcitabine
n=108 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=110 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 9.98 • n=99 Participants
|
61.7 years
STANDARD_DEVIATION 9.68 • n=107 Participants
|
61.2 years
STANDARD_DEVIATION 9.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
130 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
|
35 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
115 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
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
13 participants
n=99 Participants
|
18 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
21 participants
n=99 Participants
|
13 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
France
|
20 participants
n=99 Participants
|
21 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
26 participants
n=99 Participants
|
27 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Extent of Disease at Randomization
Metastatic
|
94 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
|
Extent of Disease at Randomization
Locally Advanced
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
ECOG Performance at Randomization
0
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
ECOG Performance at Randomization
1
|
59 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=108 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=110 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Overall Survival
|
226 days
Interval 183.0 to 278.0
|
209 days
Interval 158.0 to 248.0
|
SECONDARY outcome
Timeframe: From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=108 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=110 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Progression Free Survival (PFS)
|
113 days
Interval 79.0 to 168.0
|
110 days
Interval 60.0 to 115.0
|
SECONDARY outcome
Timeframe: Up to approximately 33.5 months (assessed continuously during treatment)Population: Of the 108 subjects that received EndoTAG-1 and Gemcitabine, 11 subjects (11.46%, 11/96) presented with a complete or partial response. There were 6 subjects (6.82%, 6/88) that received Gemcitabine Monotherapy considered to have an objective response. For 12 subjects in the EndoTAG-1 group and 22 subjects in the Gemcitabine Monotherapy group, objective response assessments were missing.
Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=96 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=88 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Percentage of Subjects With Objective Response
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause.Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=11 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=6 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Duration of Response
|
5.8 Months
Standard Deviation 2.62
|
9.1 Months
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Up to approximately 33.5 months (assessed continuously during treatment)Population: There were 12 subjects in the EndoTAG-1 treated group and 22 subjects in the Gemcitabine Monotherapy group that were not included in analysis due to missing records.
Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=96 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=88 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Percentage of Subjects With Disease Control According to RECIST v.1.1
|
57 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=108 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=110 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))Population: Some missing data (Change from baseline is based on subjects with paired values.)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=108 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=110 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Pancreatic pain
|
1.0 score on a scale
Standard Deviation 3.0
|
1.7 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Digestive
|
0.6 score on a scale
Standard Deviation 2.1
|
0.9 score on a scale
Standard Deviation 1.6
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Altered bowel habit
|
0.5 score on a scale
Standard Deviation 1.8
|
-0.1 score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Hepatic
|
0.0 score on a scale
Standard Deviation 0.9
|
0.0 score on a scale
Standard Deviation 1.1
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Body image
|
0.6 score on a scale
Standard Deviation 1.8
|
0.7 score on a scale
Standard Deviation 1.9
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Health care satisfaction
|
0.8 score on a scale
Standard Deviation 1.6
|
0.4 score on a scale
Standard Deviation 1.6
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Sexuality
|
-0.1 score on a scale
Standard Deviation 2.4
|
0.8 score on a scale
Standard Deviation 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))Population: Some missing data (Change from baseline is based on subjects with paired values.)
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score.
Outcome measures
| Measure |
EndoTAG-1 and Gemcitabine
n=108 Participants
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=110 Participants
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Global health QoL
|
-1.6 score on a scale
Standard Deviation 2.7
|
-2.0 score on a scale
Standard Deviation 2.7
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Functional scales
|
5.4 score on a scale
Standard Deviation 8.2
|
6.9 score on a scale
Standard Deviation 9.0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Symptom scales
|
2.6 score on a scale
Standard Deviation 4.4
|
2.6 score on a scale
Standard Deviation 4.5
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Side effect scales
|
1.3 score on a scale
Standard Deviation 2.6
|
1.4 score on a scale
Standard Deviation 3.0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Physical
|
2.0 score on a scale
Standard Deviation 3.1
|
2.4 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Role
|
1.1 score on a scale
Standard Deviation 1.7
|
1.4 score on a scale
Standard Deviation 1.9
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Cognitive
|
0.5 score on a scale
Standard Deviation 1.2
|
0.6 score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Emotional
|
1.2 score on a scale
Standard Deviation 2.6
|
1.6 score on a scale
Standard Deviation 3.0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Social
|
0.6 score on a scale
Standard Deviation 1.7
|
0.9 score on a scale
Standard Deviation 1.6
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Fatigue
|
1.5 score on a scale
Standard Deviation 2.2
|
1.4 score on a scale
Standard Deviation 2.1
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Pain
|
0.7 score on a scale
Standard Deviation 1.8
|
0.9 score on a scale
Standard Deviation 2.0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Nausea/vomiting
|
0.4 score on a scale
Standard Deviation 1.5
|
0.2 score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Dyspnoea
|
0.5 score on a scale
Standard Deviation 0.9
|
0.6 score on a scale
Standard Deviation 0.9
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Appetite loss
|
0.5 score on a scale
Standard Deviation 1.1
|
0.3 score on a scale
Standard Deviation 0.9
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Insomnia
|
0.0 score on a scale
Standard Deviation 0.9
|
0.2 score on a scale
Standard Deviation 1.2
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Constipation/diarrhea
|
0.4 score on a scale
Standard Deviation 1.2
|
0.4 score on a scale
Standard Deviation 1.2
|
Adverse Events
EndoTAG-1 and Gemcitabine
Serious events: 52 serious events
Other events: 101 other events
Deaths: 91 deaths
Gemcitabine Monotherapy
Serious events: 48 serious events
Other events: 100 other events
Deaths: 85 deaths
Serious adverse events
| Measure |
EndoTAG-1 and Gemcitabine
n=102 participants at risk
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=102 participants at risk
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
4/102 • Number of events 4 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Cardiac disorders
Cardiac arrest
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Cardiac disorders
Cardiac failure
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
6/102 • Number of events 8 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
4.9%
5/102 • Number of events 5 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Ascites
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Colitis erosive
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.9%
3/102 • Number of events 3 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Subileus
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Asthenia
|
2.9%
3/102 • Number of events 3 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Death
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
3.9%
4/102 • Number of events 4 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
General physical health deterioration
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Generalised oedema
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Influenza like illness
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Pyrexia
|
6.9%
7/102 • Number of events 8 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.9%
3/102 • Number of events 3 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Hepatobiliary disorders
Malignant biliary obstruction
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Atypical pneumonia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Bacteraemia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Biliary tract infection
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Empyema
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Escherichia bacteraemia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Febrile infection
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Liver abscess
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Peritonitis
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Pneumonia
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.9%
3/102 • Number of events 3 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Sepsis
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Septic shock
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Upper respiratory tract infection
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Nervous system disorders
Cerebral ischaemia
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Nervous system disorders
Somnolence
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Psychiatric disorders
Confusional state
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Renal and urinary disorders
Haematuria
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Renal and urinary disorders
Thrombotic microangiopathy
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/102 • Number of events 2 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Vascular disorders
Deep vein thrombosis
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Vascular disorders
Hypertension
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Vascular disorders
Hypotension
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Vascular disorders
Hypovolaemic shock
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/102 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
0.98%
1/102 • Number of events 1 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
Other adverse events
| Measure |
EndoTAG-1 and Gemcitabine
n=102 participants at risk
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly
|
Gemcitabine Monotherapy
n=102 participants at risk
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly
|
|---|---|---|
|
Investigations
Platelet Count Decreased
|
40.2%
41/102 • Number of events 200 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
41.2%
42/102 • Number of events 193 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Neutrophil Count Decreased
|
17.6%
18/102 • Number of events 83 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
20.6%
21/102 • Number of events 83 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
White Blood Cell Count Decreased
|
17.6%
18/102 • Number of events 58 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
16.7%
17/102 • Number of events 71 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
17/102 • Number of events 43 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
16.7%
17/102 • Number of events 31 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Aspartate Aminotransferase Increased
|
13.7%
14/102 • Number of events 30 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
16.7%
17/102 • Number of events 29 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
10.8%
11/102 • Number of events 19 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
10.8%
11/102 • Number of events 14 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
14.7%
15/102 • Number of events 32 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
4.9%
5/102 • Number of events 9 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Weight Decreased
|
12.7%
13/102 • Number of events 19 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
3.9%
4/102 • Number of events 6 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Investigations
Lymphocyte Count Decreased
|
7.8%
8/102 • Number of events 39 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
6.9%
7/102 • Number of events 15 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.8%
9/102 • Number of events 14 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.0%
2/102 • Number of events 3 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.9%
7/102 • Number of events 7 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
3.9%
4/102 • Number of events 5 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Psychiatric disorders
Insomnia
|
8.8%
9/102 • Number of events 10 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
2.9%
3/102 • Number of events 3 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Fatigue
|
18.6%
19/102 • Number of events 35 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
15.7%
16/102 • Number of events 22 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Chills
|
17.6%
18/102 • Number of events 24 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
5.9%
6/102 • Number of events 12 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
General disorders
Oedema Peripheral
|
17.6%
18/102 • Number of events 24 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
5.9%
6/102 • Number of events 12 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
34.3%
35/102 • Number of events 42 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
21.6%
22/102 • Number of events 28 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.8%
8/102 • Number of events 13 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
4.9%
5/102 • Number of events 9 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Constipation
|
19.6%
20/102 • Number of events 22 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
19.6%
20/102 • Number of events 24 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.8%
8/102 • Number of events 9 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
6.9%
7/102 • Number of events 9 • Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy. Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
|
Additional Information
Albert Lin, Ph.D./Special Assistant to GM
SynCore Biotechnology Co., Ltd.
Phone: +886-2-2760-3688
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60