Trial Outcomes & Findings for Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma (NCT NCT03943667)
NCT ID: NCT03943667
Last Updated: 2026-01-15
Results Overview
Time from the date of randomization to the date of death from any cause
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
Until death (life expectancy around 12 months)
Results posted on
2026-01-15
Participant Flow
Participant milestones
| Measure |
GEMPAX
Gemcitabine + Paclitaxel until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
|
Control
Gemcitabine alone until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
71
|
|
Overall Study
COMPLETED
|
140
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GEMPAX
n=140 Participants
Gemcitabine + Paclitaxel until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
|
Control
n=71 Participants
Gemcitabine alone until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
70 Participants
n=140 Participants
|
35 Participants
n=71 Participants
|
105 Participants
n=211 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=140 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=211 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=140 Participants
|
36 Participants
n=71 Participants
|
106 Participants
n=211 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=140 Participants
|
28 Participants
n=71 Participants
|
81 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=140 Participants
|
43 Participants
n=71 Participants
|
130 Participants
n=211 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
140 participants
n=140 Participants
|
71 participants
n=71 Participants
|
211 participants
n=211 Participants
|
PRIMARY outcome
Timeframe: Until death (life expectancy around 12 months)Time from the date of randomization to the date of death from any cause
Outcome measures
| Measure |
GEMPAX
n=140 Participants
Gemcitabine + Paclitaxel until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
|
Control
n=71 Participants
Gemcitabine alone until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
|
|---|---|---|
|
Overall Survival
|
6.4 months
Interval 5.2 to 7.4
|
5.9 months
Interval 4.6 to 6.9
|
Adverse Events
GEMPAX
Serious events: 71 serious events
Other events: 138 other events
Deaths: 131 deaths
Control
Serious events: 26 serious events
Other events: 22 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
GEMPAX
n=140 participants at risk
Gemcitabine + Paclitaxel until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
|
Control
n=71 participants at risk
Gemcitabine alone until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
7/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
BICYTOPENIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
HYPERTHERMIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.1%
3/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Congenital, familial and genetic disorders
APLASIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Eye disorders
VISION BLURRED
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.0%
7/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
2.8%
2/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
ANASTOMOTIC ULCER PERFORATION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
ASCITES
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
2.1%
3/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
5.0%
7/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
2.8%
2/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
SUBILEUS
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
4/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
ASTHENIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
GENERA PHYSICAL HEALTH DETERIORATION
|
2.9%
4/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
2.8%
2/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
HYPOTHERMIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
PYREXIA
|
2.1%
3/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
BILIARY OBSTRUCTION
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
4.2%
3/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
2.9%
4/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
2.8%
2/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
CHOLECYSTITITS ACUTE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
2.8%
2/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
BACTERAEMIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
BILIARY SEPSIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
BILIARY TRACT INFECTION
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
INJECTION SITE INFECTION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
PNEUMONIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
SEPSIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
VASCULAR ACCESS SITE INFECTION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Metabolism and nutrition disorders
STARVATION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
COMA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
DYSKINESIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
PSYCHOMOTOR SKILLS IMPAIRED
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
SCIATICA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
4.2%
3/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.1%
3/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
Other adverse events
| Measure |
GEMPAX
n=140 participants at risk
Gemcitabine + Paclitaxel until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
|
Control
n=71 participants at risk
Gemcitabine alone until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
STOMATITIS
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
VOMITING
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
15.7%
22/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
15.5%
11/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
14.3%
20/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
4.2%
3/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Congenital, familial and genetic disorders
APLASIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
15.0%
21/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
4.2%
3/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
ASTHENIA
|
10.0%
14/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
2.8%
2/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
General disorders
MUCOSAL INFLAMMATION
|
2.1%
3/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Hepatobiliary disorders
HEPATIC CYTOLISIS
|
2.9%
4/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
1.4%
2/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
5.0%
7/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.9%
4/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
12.1%
17/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
NEUROTOXICITY
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
PARAESTHESIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUTROPATHY
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
1.4%
1/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSITIAL LUNG DISEASE
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
4.3%
6/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
0.71%
1/140 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
0.00%
0/71 • GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
|
Additional Information
Dr Christelle DE LA FOUCHARDIERE
Institut Paoli Calmettes
Phone: +33(0)491223333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place