Trial Outcomes & Findings for An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer (NCT NCT00570713)
NCT ID: NCT00570713
Last Updated: 2015-09-09
Results Overview
This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
1-21 Months
Results posted on
2015-09-09
Participant Flow
Participants were recruited from a population of pancreatic cancer patients treated at investigational centers.
Participant milestones
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
78
|
77
|
Reasons for withdrawal
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
9
|
|
Overall Study
Death
|
7
|
7
|
|
Overall Study
Lack of Efficacy
|
40
|
49
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Discontinuation of Study by the Sponsor
|
10
|
7
|
Baseline Characteristics
An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
n=78 Participants
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
n=77 Participants
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
78 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
65.8 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
65.0 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
69 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
North America
|
57 participants
n=99 Participants
|
57 participants
n=107 Participants
|
114 participants
n=206 Participants
|
|
Region of Enrollment
Europe
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1-21 MonthsThis measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.
Outcome measures
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
n=78 Participants
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
n=77 Participants
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Overall Survival (OS)
|
6.5 Months
Interval 4.5 to 8.1
|
6.9 Months
Interval 5.4 to 8.8
|
SECONDARY outcome
Timeframe: 1-21 MonthsProgression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.
Outcome measures
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
n=78 Participants
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
n=77 Participants
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Progression-free Survival
|
3.4 Months
Interval 1.9 to 4.7
|
3.5 Months
Interval 2.8 to 4.9
|
SECONDARY outcome
Timeframe: Baseline to response up to 21 monthsBest overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.
Outcome measures
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
n=78 Participants
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
n=77 Participants
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Best Overall Response Rate
Complete or Partial Response
|
6.4 percentage of participants
|
7.8 percentage of participants
|
|
Best Overall Response Rate
Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate
Partial Response
|
6.4 percentage of participants
|
7.8 percentage of participants
|
|
Best Overall Response Rate
Stable Disease
|
47.4 percentage of participants
|
55.8 percentage of participants
|
|
Best Overall Response Rate
Progressive Disease
|
19.2 percentage of participants
|
23.4 percentage of participants
|
|
Best Overall Response Rate
Not Evaluable
|
26.9 percentage of participants
|
13.0 percentage of participants
|
Adverse Events
MORAb-009 Plus Gemcitabine ('MORAb-009')
Serious events: 49 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo Plus Gemcitabine ('Placebo')
Serious events: 54 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
n=73 participants at risk
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
n=75 participants at risk
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Ileus
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
17.8%
13/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
14.7%
11/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Cholangitis
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Cholestasis
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Jaundice
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Pneumonia
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Sepsis
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Biliary Sepsis
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Septic shock
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Viral infection
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Asthenia
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
General physical health deterioration
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Pyrexia
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Chest pain
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Generalized oedema
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Chills
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Multi-organ failure
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Performance status decreased
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
9.3%
7/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
9.3%
7/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Poor venous access
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Thromboangiitis obliterans
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Venous thrombosis
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Cerebral infarction
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Convulsion
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Ischaemic stroke
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Tremor
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Immune system disorders
Hypersensitivity
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
International normalized ratio increased
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Surgical and medical procedures
Parenteral nutrition
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
Other adverse events
| Measure |
MORAb-009 Plus Gemcitabine ('MORAb-009')
n=73 participants at risk
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
Placebo Plus Gemcitabine ('Placebo')
n=75 participants at risk
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
47.9%
35/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
50.7%
38/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Constipation
|
46.6%
34/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
36.0%
27/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.0%
27/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
26.7%
20/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Vomiting
|
31.5%
23/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
32.0%
24/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.1%
22/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
30.7%
23/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Abdominal distention
|
16.4%
12/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
13.3%
10/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
14.7%
11/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Ascites
|
11.0%
8/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Flatulence
|
12.3%
9/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Gastrointestinal disorders
Stomatitis
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Fatigue
|
43.8%
32/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
42.7%
32/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Oedema peripheral
|
37.0%
27/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
30.7%
23/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Pyrexia
|
17.8%
13/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
34.7%
26/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Asthenia
|
20.5%
15/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
24.0%
18/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Chills
|
17.8%
13/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
18.7%
14/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Oedema
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Pain
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
9.3%
7/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
Chest pain
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
General disorders
General physical health deterioration
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.6%
26/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
33.3%
25/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Dehydration
|
17.8%
13/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
20.0%
15/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.4%
12/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
17.3%
13/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
9.3%
7/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Anaemia
|
43.8%
32/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
48.0%
36/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.2%
25/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
33.3%
25/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.9%
16/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
26.7%
20/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.1%
11/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
21.3%
16/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Weight decreased
|
13.7%
10/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
12.0%
9/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Blood alkaline Phosphatase increased
|
12.3%
9/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
10.7%
8/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Alanine aminotransferase increased
|
11.0%
8/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Aspartate aminotransferase increased
|
11.0%
8/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Neutrophil count decreased
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Haemoglobin decreased
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Blood bilirubin increased
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
Platelet count decreased
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Investigations
International normalised ratio increased
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Urinary tract infection
|
16.4%
12/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
13.3%
10/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Cellulitis
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
10.7%
8/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Pneumonia
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Candidiasis
|
4.1%
3/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Rhinitis
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.1%
11/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
21.3%
16/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.1%
11/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.7%
18/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
14.7%
11/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
12.0%
9/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
10.7%
8/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
4.0%
3/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.7%
10/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
18.7%
14/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
14.7%
11/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Dizziness
|
16.4%
12/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
16.0%
12/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Headache
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
12.0%
9/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Dysgeusia
|
8.2%
6/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Deep vein thrombosis
|
9.6%
7/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
14.7%
11/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Hypertension
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
13.3%
10/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Hypotension
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Vascular disorders
Pallor
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
0.00%
0/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Insomnia
|
17.8%
13/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
13.3%
10/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Anxiety
|
11.0%
8/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
8.0%
6/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Depression
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Sleep disorder
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
6.7%
5/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Psychiatric disorders
Confusional state
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
1.3%
1/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.8%
5/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
10.7%
8/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Cholangitis
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Hepatobiliary disorders
Jaundice
|
2.7%
2/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
17.8%
13/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
14.7%
11/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Cardiac disorders
Palpitations
|
5.5%
4/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
2.7%
2/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/73 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
5.3%
4/75 • From Baseline up to 21 months.
73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60