Trial Outcomes & Findings for Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas (NCT NCT01088815)
NCT ID: NCT01088815
Last Updated: 2019-04-26
Results Overview
Number of months from time first therapy received to the earliest documented disease progression or death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
6 years
Results posted on
2019-04-26
Participant Flow
98 subjects signed consents in total. 26 subjects were screen-fails
Participant milestones
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=72 Participants
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=113 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=113 Participants
|
|
Age, Continuous
|
62.05 years
n=113 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Data for this outcome measure was evaluable in only in 67/72 participants.
Number of months from time first therapy received to the earliest documented disease progression or death from any cause.
Outcome measures
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=67 Participants
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Progression Free Survival With the Combination of GDC-0449 With Gemcitabine and Nab-paclitaxel.
|
5.42 months
Interval 4.37 to 6.97
|
PRIMARY outcome
Timeframe: 6 yearsNumber of grade 3 or 4 adverse events as defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.0) that occur after Cycle 2, Day 1
Outcome measures
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=72 Participants
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Safety of Combination Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas as Assessed by Number of Grade 3 or 4 Adverse Events
|
104 Grade 3/4 adverse events
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Data was evaluable in only 67/72 participants for this outcome measure
Total number of months alive.
Outcome measures
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=67 Participants
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Overall Survival
|
9.79 months
Interval 7.85 to 10.97
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Data was evaluable in only 67/72 participants for this outcome measure
Number of participants with complete (CR) or partial (PR) response as defined by RECIST criteria.
Outcome measures
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=67 Participants
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Tumor Response
CR
|
1 Participants
|
|
Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Tumor Response
PR
|
26 Participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Peripheral blood data was collected from only 57/72 participants. Tissue biopsy data was not evaluable for analysis due to inadequate biopsy samples for all 23/72 participants who underwent biopsy
Change in number of Pancreatic cancer stem cells in tissue and peripheral blood in tissue biopsy and peripheral blood.
Outcome measures
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=72 Participants
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Changes in Pancreatic Cancer Stem Cell
peripheral blood
|
27.0 cells
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Data was not collected for this outcome measure.
Hedgehog signaling pathway downregulation as measured by Gli-1 and Patch expression
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine, Nab-paclitaxel, GDC-0449
Serious events: 46 serious events
Other events: 72 other events
Deaths: 64 deaths
Serious adverse events
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=72 participants at risk
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Blood and lymphatic system disorders
Abdominal Distension
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Blood and lymphatic system disorders
Blood Bilirubin Increased
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Blood and lymphatic system disorders
Blood/Lymph Disorder
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Death
|
6.9%
5/72 • Number of events 5 • 6 years
|
|
Metabolism and nutrition disorders
Dehyrdation
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Fatigue
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Fever
|
11.1%
8/72 • Number of events 9 • 6 years
|
|
Gastrointestinal disorders
Gallbladder Infection
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Gastroparesis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
General Disorders/Administration Site
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
GI disorders
|
2.8%
2/72 • Number of events 3 • 6 years
|
|
Cardiac disorders
Heart Failure
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Vascular disorders
Hematoma
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Hepatobiliary disorders
Hepatobil Disorders
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Vascular disorders
Hypotension
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Eye disorders
Ileus
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Infections and infestations
Infestion/Infestation-Other
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Investigations
Investigations-Other
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Renal and urinary disorders
Kidney Infection
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Lethargy
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Neutrophil Count Decreased
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Gastrointestinal disorders
Obstruction Gastric
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Pericardial Effusion
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Platelet Count Decreased
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory/Thoracic/Mediastinal Disorder
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Infections and infestations
Sepsis
|
8.3%
6/72 • Number of events 6 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Infections and infestations
Splenic Infection
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Stroke
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Vascular disorders
Thromboembolic
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Gastrointestinal disorders
Upper GI Hemorrhage
|
2.8%
2/72 • Number of events 4 • 6 years
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Vascular disorders
Vascular Access Complication
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Infections and infestations
Wound Infection
|
1.4%
1/72 • Number of events 1 • 6 years
|
Other adverse events
| Measure |
Gemcitabine, Nab-paclitaxel, GDC-0449
n=72 participants at risk
Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)
Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
6.9%
5/72 • Number of events 5 • 6 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.4%
19/72 • Number of events 23 • 6 years
|
|
Psychiatric disorders
Agitation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Alkaline Phosphatase Increased
|
31.9%
23/72 • Number of events 38 • 6 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
63.9%
46/72 • Number of events 58 • 6 years
|
|
Investigations
ALT Increased
|
47.2%
34/72 • Number of events 60 • 6 years
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
77.8%
56/72 • Number of events 232 • 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
36.1%
26/72 • Number of events 37 • 6 years
|
|
Psychiatric disorders
Anxiety
|
9.7%
7/72 • Number of events 7 • 6 years
|
|
Investigations
APTT Prolonged
|
5.6%
4/72 • Number of events 7 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Gastrointestinal disorders
Ascites
|
16.7%
12/72 • Number of events 14 • 6 years
|
|
Investigations
AST Increased
|
48.6%
35/72 • Number of events 53 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.5%
9/72 • Number of events 9 • 6 years
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Atrial Flutter
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
6/72 • Number of events 6 • 6 years
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Bloating
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Blood and lymphatic system disorders
Blood Bilirubin Increased
|
16.7%
12/72 • Number of events 19 • 6 years
|
|
Blood and lymphatic system disorders
Blood/Lymph Disorder
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Reproductive system and breast disorders
Breast Pain
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.9%
5/72 • Number of events 5 • 6 years
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Cardiac Troponin I Increased
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Cardiac Troponin T Increased
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
CD34 Lymphocytes Decreased
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Chest Pain - Cardiac
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Chills
|
19.4%
14/72 • Number of events 15 • 6 years
|
|
Psychiatric disorders
Concentration Impairment
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Psychiatric disorders
Confusion
|
5.6%
4/72 • Number of events 7 • 6 years
|
|
Gastrointestinal disorders
Constipation
|
23.6%
17/72 • Number of events 21 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.6%
17/72 • Number of events 19 • 6 years
|
|
Investigations
CPK Increased
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Creatinine Increased
|
12.5%
9/72 • Number of events 11 • 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
15.3%
11/72 • Number of events 37 • 6 years
|
|
Psychiatric disorders
Depression
|
8.3%
6/72 • Number of events 6 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
30/72 • Number of events 43 • 6 years
|
|
Nervous system disorders
Dizziness
|
25.0%
18/72 • Number of events 18 • 6 years
|
|
Eye disorders
Dry Eye
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Dry Mouth
|
8.3%
6/72 • Number of events 8 • 6 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.6%
4/72 • Number of events 5 • 6 years
|
|
Gastrointestinal disorders
Duodenal Perforation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Dysarthria
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Dysgeusia
|
73.6%
53/72 • Number of events 74 • 6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Gastrointestinal disorders
dysphagia
|
2.8%
2/72 • Number of events 3 • 6 years
|
|
Nervous system disorders
Dysphasia
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.9%
23/72 • Number of events 30 • 6 years
|
|
Cardiac disorders
ECG QT Corrected int prolong
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Edema Face
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Edema Limbs
|
38.9%
28/72 • Number of events 52 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.9%
10/72 • Number of events 10 • 6 years
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
4.2%
3/72 • Number of events 5 • 6 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
1.4%
1/72 • Number of events 3 • 6 years
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Extrapyramidal Disorder
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Eye disorders
Eye Disorder - Other
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Nervous system disorders
Facial Nerve Disorder
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Fatigue
|
68.1%
49/72 • Number of events 97 • 6 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Fever
|
30.6%
22/72 • Number of events 38 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
6/72 • Number of events 6 • 6 years
|
|
General disorders
Flu like symptoms
|
16.7%
12/72 • Number of events 16 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
General disorders
Gait Disturbance
|
5.6%
4/72 • Number of events 5 • 6 years
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
General disorders
General disorders/admin site conditions
|
6.9%
5/72 • Number of events 5 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
8.3%
6/72 • Number of events 8 • 6 years
|
|
Reproductive system and breast disorders
Genital Edema
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Gastrointestinal disorders
GERD
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Gastrointestinal disorders
GI disorders - other
|
15.3%
11/72 • Number of events 14 • 6 years
|
|
Psychiatric disorders
Hallucinations
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Headache
|
8.3%
6/72 • Number of events 8 • 6 years
|
|
Vascular disorders
Hematoma
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Renal and urinary disorders
Hematuria
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Hepatobiliary disorders
Hepatobil disorders - other
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.1%
31/72 • Number of events 65 • 6 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
12/72 • Number of events 15 • 6 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.9%
5/72 • Number of events 6 • 6 years
|
|
Vascular disorders
Hypertension
|
2.8%
2/72 • Number of events 3 • 6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.8%
33/72 • Number of events 91 • 6 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
40.3%
29/72 • Number of events 60 • 6 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.2%
3/72 • Number of events 5 • 6 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.8%
20/72 • Number of events 37 • 6 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
9/72 • Number of events 15 • 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
24/72 • Number of events 47 • 6 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.3%
11/72 • Number of events 19 • 6 years
|
|
Vascular disorders
Hypotension
|
16.7%
12/72 • Number of events 19 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Infections and infestations
Infections/Infestactions - Other
|
13.9%
10/72 • Number of events 13 • 6 years
|
|
Injury, poisoning and procedural complications
Infusion site extravasation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
INR Increased
|
11.1%
8/72 • Number of events 10 • 6 years
|
|
Psychiatric disorders
Insomnia
|
8.3%
6/72 • Number of events 6 • 6 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Investigations-Other, specify
|
11.1%
8/72 • Number of events 12 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Lethargy
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Investigations
Lipase increased
|
2.8%
2/72 • Number of events 3 • 6 years
|
|
General disorders
Localized edema
|
6.9%
5/72 • Number of events 5 • 6 years
|
|
Infections and infestations
Lung infection
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Investigations
Lymphocyte count decreased
|
56.9%
41/72 • Number of events 175 • 6 years
|
|
Investigations
Lymphocyte count increased
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
General disorders
Malaise
|
2.8%
2/72 • Number of events 4 • 6 years
|
|
Metabolism and nutrition disorders
Metabolism/nutrition disorders-Other
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
16.7%
12/72 • Number of events 24 • 6 years
|
|
Infections and infestations
Mucosal infection
|
4.2%
3/72 • Number of events 4 • 6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
8/72 • Number of events 9 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
9/72 • Number of events 12 • 6 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
56.9%
41/72 • Number of events 56 • 6 years
|
|
Skin and subcutaneous tissue disorders
Neck Edema
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Nervous system disorders - other
|
8.3%
6/72 • Number of events 8 • 6 years
|
|
Investigations
Neutrophil count decreased
|
56.9%
41/72 • Number of events 138 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Non-Cardiac Chest Pain
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Nervous system disorders
Oculomotor nerve disorder
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Oral Pain
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
General disorders
Pain
|
15.3%
11/72 • Number of events 12 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
6/72 • Number of events 7 • 6 years
|
|
Nervous system disorders
Paresthesia
|
12.5%
9/72 • Number of events 17 • 6 years
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
6/72 • Number of events 7 • 6 years
|
|
Gastrointestinal disorders
Periodontal disease
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
22.2%
16/72 • Number of events 27 • 6 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
36/72 • Number of events 77 • 6 years
|
|
Eye disorders
Photophobia
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Platelet count decreased
|
61.1%
44/72 • Number of events 155 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
19.4%
14/72 • Number of events 15 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
13.9%
10/72 • Number of events 10 • 6 years
|
|
Nervous system disorders
Presyncope
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Renal and urinary disorders
Proteinuria
|
6.9%
5/72 • Number of events 6 • 6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
12/72 • Number of events 14 • 6 years
|
|
Psychiatric disorders
Psych disorders-Other, spec
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
41.7%
30/72 • Number of events 36 • 6 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.3%
11/72 • Number of events 19 • 6 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.4%
1/72 • Number of events 3 • 6 years
|
|
Renal and urinary disorders
Renal/urinary disorders-Other
|
5.6%
4/72 • Number of events 5 • 6 years
|
|
Reproductive system and breast disorders
Repro system/breast ds-Oth
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp/thoracic/mediastinal ds
|
2.8%
2/72 • Number of events 3 • 6 years
|
|
Nervous system disorders
Restlessness
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Cardiac disorders
Right ventricular dysfunction
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Nervous system disorders
Seizure
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Infections and infestations
Sinusitis
|
6.9%
5/72 • Number of events 5 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Infections and infestations
Skin infection
|
9.7%
7/72 • Number of events 11 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin/subq tissue ds-Other
|
12.5%
9/72 • Number of events 17 • 6 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Stomach Pain
|
2.8%
2/72 • Number of events 3 • 6 years
|
|
Cardiac disorders
Syncope
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Vascular disorders
Thromboembolic event
|
22.2%
16/72 • Number of events 17 • 6 years
|
|
Nervous system disorders
Tremor
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.2%
3/72 • Number of events 5 • 6 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
2/72 • Number of events 2 • 6 years
|
|
Renal and urinary disorders
Urinary tract infection
|
5.6%
4/72 • Number of events 4 • 6 years
|
|
Renal and urinary disorders
Urine discoloration
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Vascular disorders
Vasc disorders-Other, spec
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
30/72 • Number of events 40 • 6 years
|
|
Eye disorders
Watering eyes
|
1.4%
1/72 • Number of events 1 • 6 years
|
|
Investigations
Weight gain
|
4.2%
3/72 • Number of events 3 • 6 years
|
|
Investigations
Weight loss
|
22.2%
16/72 • Number of events 26 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.4%
1/72 • Number of events 2 • 6 years
|
|
Investigations
White blood cell decreased
|
70.8%
51/72 • Number of events 285 • 6 years
|
|
Infections and infestations
Wound infection
|
2.8%
2/72 • Number of events 4 • 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place