Trial Outcomes & Findings for Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer (NCT NCT00380588)
NCT ID: NCT00380588
Last Updated: 2009-11-20
Results Overview
Percentage of patients alive at 1 year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
1 year
Results posted on
2009-11-20
Participant Flow
Participant milestones
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
Received at Least One Dose of Study Drug
|
41
|
42
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
39
|
40
|
Reasons for withdrawal
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Overall Study
Unequivocal Disease Progression
|
25
|
34
|
|
Overall Study
Next Cycle Not Started
|
4
|
0
|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Cisplatin
n=41 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
41 participants
n=5 Participants
|
42 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
34 participants
n=5 Participants
|
28 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
7 participants
n=5 Participants
|
14 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Primary Tumor
Extrahepatic Bile Duct
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Primary Tumor
Intrahepatic Bile Duct
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Primary Tumor
Gallbladder
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Primary Tumor
Papilla
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Tumor Histological Type
Adenocarcinoma
|
39 participants
n=5 Participants
|
41 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Tumor Histological Type
Adenosquamous Cancer
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Body Surface Area
|
1.555 square meter (m^2)
STANDARD_DEVIATION 0.195 • n=5 Participants
|
1.523 square meter (m^2)
STANDARD_DEVIATION 0.158 • n=7 Participants
|
1.539 square meter (m^2)
STANDARD_DEVIATION 0.177 • n=5 Participants
|
|
Height
|
159.80 centimeters (cm)
STANDARD_DEVIATION 8.75 • n=5 Participants
|
156.67 centimeters (cm)
STANDARD_DEVIATION 8.62 • n=7 Participants
|
158.21 centimeters (cm)
STANDARD_DEVIATION 8.77 • n=5 Participants
|
|
Weight
|
54.97 kilograms (kg)
STANDARD_DEVIATION 12.31 • n=5 Participants
|
53.91 kilograms (kg)
STANDARD_DEVIATION 9.50 • n=7 Participants
|
54.43 kilograms (kg)
STANDARD_DEVIATION 10.92 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Number of patients who received at least one dose of study drug.
Percentage of patients alive at 1 year.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=41 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
|
39 percentage of participants
|
31 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (up to 2 years)Population: Number of patients who received at least one dose of study drug.
Response Evaluation Criteria In Solid Tumors - define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=41 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Tumor Response
Progressive Disease
|
9 participants
|
17 participants
|
|
Tumor Response
Not Evaluable
|
4 participants
|
4 participants
|
|
Tumor Response
Complete Response
|
0 participants
|
0 participants
|
|
Tumor Response
Partial Response
|
8 participants
|
5 participants
|
|
Tumor Response
Stable Disease
|
20 participants
|
16 participants
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease (up to 2 years)Population: Number of patients who received at least one dose of study drug.
The period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=41 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Progression Free Survival
|
5.8 months
Interval 4.1 to 8.2
|
3.7 months
Interval 2.1 to 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to date of death due to any cause (up to 2 years)Data of patients lost to follow-up were censored at the last date of confirmation of their survival.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=41 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 Participants
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Survival Time
|
11.2 months
Interval 9.1 to 12.5
|
7.7 months
Interval 6.1 to 11.0
|
Adverse Events
Gemcitabine + Cisplatin
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
Gemcitabine
Serious events: 17 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Cisplatin
n=41 participants at risk
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 participants at risk
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Duodenal stenosis
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
9.8%
4/41 • Number of events 4
|
19.0%
8/42 • Number of events 19
|
|
Hepatobiliary disorders
Haemobilia
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
4.9%
2/41 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Liver abscess
|
4.9%
2/41 • Number of events 3
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/41
|
2.4%
1/42 • Number of events 10
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/41
|
2.4%
1/42 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Platelet count decreased
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine + Cisplatin
n=41 participants at risk
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
Gemcitabine
n=42 participants at risk
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
4/41 • Number of events 6
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
4.9%
2/41 • Number of events 3
|
9.5%
4/42 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
6/41 • Number of events 7
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Number of events 2
|
9.5%
4/42 • Number of events 6
|
|
Gastrointestinal disorders
Ascites
|
7.3%
3/41 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
36.6%
15/41 • Number of events 30
|
33.3%
14/42 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhoea
|
31.7%
13/41 • Number of events 31
|
26.2%
11/42 • Number of events 20
|
|
Gastrointestinal disorders
Nausea
|
68.3%
28/41 • Number of events 100
|
42.9%
18/42 • Number of events 54
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
5/41 • Number of events 5
|
11.9%
5/42 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
48.8%
20/41 • Number of events 50
|
23.8%
10/42 • Number of events 26
|
|
General disorders
Fatigue
|
58.5%
24/41 • Number of events 67
|
50.0%
21/42 • Number of events 104
|
|
General disorders
Malaise
|
17.1%
7/41 • Number of events 11
|
14.3%
6/42 • Number of events 10
|
|
General disorders
Oedema
|
2.4%
1/41 • Number of events 2
|
14.3%
6/42 • Number of events 7
|
|
General disorders
Oedema peripheral
|
9.8%
4/41 • Number of events 5
|
11.9%
5/42 • Number of events 5
|
|
General disorders
Pyrexia
|
43.9%
18/41 • Number of events 28
|
59.5%
25/42 • Number of events 88
|
|
Hepatobiliary disorders
Cholangitis
|
7.3%
3/41 • Number of events 3
|
11.9%
5/42 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
17.1%
7/41 • Number of events 10
|
26.2%
11/42 • Number of events 15
|
|
Investigations
Alanine aminotransferase increased
|
51.2%
21/41 • Number of events 34
|
52.4%
22/42 • Number of events 67
|
|
Investigations
Aspartate aminotransferase increased
|
53.7%
22/41 • Number of events 35
|
52.4%
22/42 • Number of events 74
|
|
Investigations
Blood albumin decreased
|
22.0%
9/41 • Number of events 16
|
52.4%
22/42 • Number of events 49
|
|
Investigations
Blood alkaline phosphatase increased
|
31.7%
13/41 • Number of events 18
|
40.5%
17/42 • Number of events 29
|
|
Investigations
Blood amylase increased
|
7.3%
3/41 • Number of events 3
|
7.1%
3/42 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
19.5%
8/41 • Number of events 13
|
28.6%
12/42 • Number of events 18
|
|
Investigations
Blood chloride decreased
|
14.6%
6/41 • Number of events 13
|
11.9%
5/42 • Number of events 6
|
|
Investigations
Blood cholesterol decreased
|
0.00%
0/41
|
7.1%
3/42 • Number of events 3
|
|
Investigations
Blood cholinesterase decreased
|
7.3%
3/41 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
19.5%
8/41 • Number of events 30
|
14.3%
6/42 • Number of events 8
|
|
Investigations
Blood glucose increased
|
12.2%
5/41 • Number of events 8
|
11.9%
5/42 • Number of events 6
|
|
Investigations
Blood lactate dehydrogenase increased
|
36.6%
15/41 • Number of events 30
|
35.7%
15/42 • Number of events 37
|
|
Investigations
Blood potassium decreased
|
17.1%
7/41 • Number of events 17
|
9.5%
4/42 • Number of events 5
|
|
Investigations
Blood potassium increased
|
17.1%
7/41 • Number of events 27
|
14.3%
6/42 • Number of events 24
|
|
Investigations
Blood sodium decreased
|
31.7%
13/41 • Number of events 35
|
19.0%
8/42 • Number of events 11
|
|
Investigations
Blood urea increased
|
12.2%
5/41 • Number of events 20
|
21.4%
9/42 • Number of events 19
|
|
Investigations
C-reactive protein increased
|
26.8%
11/41 • Number of events 17
|
52.4%
22/42 • Number of events 40
|
|
Investigations
Creatinine renal clearance decreased
|
12.2%
5/41 • Number of events 19
|
0.00%
0/42
|
|
Investigations
Gamma-glutamyltransferase increased
|
46.3%
19/41 • Number of events 32
|
50.0%
21/42 • Number of events 47
|
|
Investigations
Glucose urine present
|
7.3%
3/41 • Number of events 6
|
9.5%
4/42 • Number of events 12
|
|
Investigations
Haematocrit decreased
|
58.5%
24/41 • Number of events 41
|
54.8%
23/42 • Number of events 48
|
|
Investigations
Haemoglobin decreased
|
85.4%
35/41 • Number of events 69
|
85.7%
36/42 • Number of events 94
|
|
Investigations
Neutrophil count decreased
|
82.9%
34/41 • Number of events 164
|
69.0%
29/42 • Number of events 115
|
|
Investigations
Neutrophil count increased
|
24.4%
10/41 • Number of events 15
|
38.1%
16/42 • Number of events 27
|
|
Investigations
Platelet count decreased
|
80.5%
33/41 • Number of events 167
|
76.2%
32/42 • Number of events 125
|
|
Investigations
Platelet count increased
|
12.2%
5/41 • Number of events 14
|
45.2%
19/42 • Number of events 54
|
|
Investigations
Protein total decreased
|
22.0%
9/41 • Number of events 26
|
38.1%
16/42 • Number of events 28
|
|
Investigations
Protein urine present
|
26.8%
11/41 • Number of events 20
|
26.2%
11/42 • Number of events 20
|
|
Investigations
Red blood cell count decreased
|
75.6%
31/41 • Number of events 52
|
78.6%
33/42 • Number of events 55
|
|
Investigations
Weight decreased
|
31.7%
13/41 • Number of events 18
|
31.0%
13/42 • Number of events 16
|
|
Investigations
Weight increased
|
12.2%
5/41 • Number of events 10
|
11.9%
5/42 • Number of events 5
|
|
Investigations
White blood cell count decreased
|
87.8%
36/41 • Number of events 153
|
69.0%
29/42 • Number of events 122
|
|
Investigations
White blood cell count increased
|
29.3%
12/41 • Number of events 22
|
54.8%
23/42 • Number of events 39
|
|
Investigations
White blood cells urine positive
|
2.4%
1/41 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
80.5%
33/41 • Number of events 110
|
61.9%
26/42 • Number of events 66
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • Number of events 3
|
0.00%
0/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
7.3%
3/41 • Number of events 6
|
11.9%
5/42 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Number of events 1
|
11.9%
5/42 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
9.8%
4/41 • Number of events 5
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • Number of events 5
|
16.7%
7/42 • Number of events 16
|
|
Nervous system disorders
Hypoaesthesia
|
9.8%
4/41 • Number of events 4
|
4.8%
2/42 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
17.1%
7/41 • Number of events 21
|
19.0%
8/42 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
1/41 • Number of events 1
|
7.1%
3/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
2/41 • Number of events 2
|
11.9%
5/42 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.8%
11/41 • Number of events 11
|
7.1%
3/42 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
5/41 • Number of events 5
|
4.8%
2/42 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.8%
11/41 • Number of events 15
|
21.4%
9/42 • Number of events 10
|
|
Surgical and medical procedures
Bile duct stent insertion
|
12.2%
5/41 • Number of events 5
|
19.0%
8/42 • Number of events 10
|
|
Surgical and medical procedures
Catheter placement
|
12.2%
5/41 • Number of events 14
|
28.6%
12/42 • Number of events 35
|
|
Vascular disorders
Angiopathy
|
7.3%
3/41 • Number of events 11
|
7.1%
3/42 • Number of events 4
|
|
Vascular disorders
Hypertension
|
0.00%
0/41
|
7.1%
3/42 • Number of events 8
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60