Trial Outcomes & Findings for Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery (NCT NCT00733746)
NCT ID: NCT00733746
Last Updated: 2019-10-21
Results Overview
The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
At 2 years post-registration
Results posted on
2019-10-21
Participant Flow
123 patients enrolled to this study. 4 patients cancelled prior to treatment and were not included in any analysis.
Participant milestones
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Overall Study
Ineligible
|
5
|
Baseline Characteristics
Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=119 Participants
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 2 years post-registrationPopulation: All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.
The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.
Outcome measures
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=74 Participants
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Overall Survival at 2 Years
|
0.54 proportion of patients
Interval 0.42 to 0.66
|
SECONDARY outcome
Timeframe: Up to 4 years postoperative chemotherapy treatmentPopulation: All patients that completed neoadjuvant treatment and were eligible for surgery were included in this endpoint.
The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval. Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles). An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins).
Outcome measures
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=97 Participants
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Resection Rate
|
0.76 proportion of patients
Interval 0.67 to 0.84
|
SECONDARY outcome
Timeframe: At 2 years post-registrationPopulation: All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.
Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=74 Participants
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Relapse/Progression-free Survival
|
11.9 months
Interval 10.8 to 17.5
|
SECONDARY outcome
Timeframe: Up to 4 years postoperative chemotherapy treatmentPopulation: All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.
Outcome measures
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=119 Participants
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
Grade 3+ Adverse Event
|
27 Participants
|
|
Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
Grade 4+ Adverse Event
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 4 years postoperative chemotherapy treatmentPopulation: All patients that completed neoadjuvant treatment and were eligible for protocol surgery were included in this endpoint.
The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.
Outcome measures
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=97 Participants
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Response Rate
|
0.06 proportion of patients
Interval 0.02 to 0.13
|
Adverse Events
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
Serious events: 37 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=119 participants at risk
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
4.2%
5/119 • Number of events 5
|
|
Cardiac disorders
Atrial tachycardia
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
2/119 • Number of events 2
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.4%
4/119 • Number of events 4
|
|
Gastrointestinal disorders
Pancreatitis
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/119 • Number of events 3
|
|
General disorders
Fatigue
|
4.2%
5/119 • Number of events 5
|
|
General disorders
Fever
|
3.4%
4/119 • Number of events 5
|
|
General disorders
Localized edema
|
0.84%
1/119 • Number of events 2
|
|
General disorders
Pain
|
0.84%
1/119 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.84%
1/119 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.84%
1/119 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
1.7%
2/119 • Number of events 2
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Biliary tract infection
|
5.0%
6/119 • Number of events 6
|
|
Infections and infestations
Endocarditis infective
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Infection
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.5%
3/119 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Biliary anastomotic leak
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
8/119 • Number of events 8
|
|
Investigations
Amylase increased
|
1.7%
2/119 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
7.6%
9/119 • Number of events 9
|
|
Investigations
Bilirubin increased
|
5.0%
6/119 • Number of events 6
|
|
Investigations
Creatinine increased
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Lipase increased
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
2.5%
3/119 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.7%
2/119 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.7%
2/119 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
1.7%
2/119 • Number of events 2
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
3/119 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
2/119 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.5%
3/119 • Number of events 3
|
Other adverse events
| Measure |
Neoadjuvant Therapy + Surgery + Adjuvant Therapy
n=119 participants at risk
Neoadjuvant Therapy:
As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
Surgery:
Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.
Adjuvant Therapy:
Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
1.7%
2/119 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
80.7%
96/119 • Number of events 146
|
|
Cardiac disorders
Atrial tachycardia
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.7%
2/119 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.84%
1/119 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
0.84%
1/119 • Number of events 1
|
|
Endocrine disorders
Endocrine disorder
|
1.7%
2/119 • Number of events 2
|
|
Endocrine disorders
Hypothyroidism
|
2.5%
3/119 • Number of events 3
|
|
Eye disorders
Conjunctival disorder
|
0.84%
1/119 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.84%
1/119 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
5.9%
7/119 • Number of events 10
|
|
Eye disorders
Eye disorder
|
0.84%
1/119 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.84%
1/119 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.84%
1/119 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.5%
3/119 • Number of events 3
|
|
Eye disorders
Watering eyes
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
3/119 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
22.7%
27/119 • Number of events 30
|
|
Gastrointestinal disorders
Ascites
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
18.5%
22/119 • Number of events 22
|
|
Gastrointestinal disorders
Diarrhea
|
48.7%
58/119 • Number of events 74
|
|
Gastrointestinal disorders
Dry mouth
|
17.6%
21/119 • Number of events 25
|
|
Gastrointestinal disorders
Dyspepsia
|
32.8%
39/119 • Number of events 43
|
|
Gastrointestinal disorders
Dysphagia
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
4.2%
5/119 • Number of events 5
|
|
Gastrointestinal disorders
Esophagitis
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
8.4%
10/119 • Number of events 11
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
4.2%
5/119 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.7%
2/119 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
7/119 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
55.5%
66/119 • Number of events 79
|
|
Gastrointestinal disorders
Oral pain
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.7%
2/119 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
34/119 • Number of events 35
|
|
General disorders
Chest pain
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Chills
|
8.4%
10/119 • Number of events 11
|
|
General disorders
Edema limbs
|
13.4%
16/119 • Number of events 17
|
|
General disorders
Facial pain
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Fatigue
|
75.6%
90/119 • Number of events 125
|
|
General disorders
Fever
|
17.6%
21/119 • Number of events 22
|
|
General disorders
Flu-like symptoms
|
1.7%
2/119 • Number of events 2
|
|
General disorders
General symptom
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Localized edema
|
1.7%
2/119 • Number of events 2
|
|
General disorders
Pain
|
9.2%
11/119 • Number of events 12
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.7%
2/119 • Number of events 2
|
|
Infections and infestations
Infection
|
1.7%
2/119 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Rhinitis infective
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.7%
2/119 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.7%
2/119 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruising
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Oral cavity NOS
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.5%
3/119 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
69.7%
83/119 • Number of events 114
|
|
Investigations
Alkaline phosphatase increased
|
20.2%
24/119 • Number of events 28
|
|
Investigations
Amylase increased
|
1.7%
2/119 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
63.9%
76/119 • Number of events 108
|
|
Investigations
Bilirubin increased
|
38.7%
46/119 • Number of events 49
|
|
Investigations
Coagulopathy
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Creatinine increased
|
8.4%
10/119 • Number of events 10
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
6/119 • Number of events 6
|
|
Investigations
INR increased
|
3.4%
4/119 • Number of events 4
|
|
Investigations
Laboratory test abnormal
|
5.0%
6/119 • Number of events 11
|
|
Investigations
Leukocyte count decreased
|
63.9%
76/119 • Number of events 109
|
|
Investigations
Lipase increased
|
1.7%
2/119 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
15.1%
18/119 • Number of events 23
|
|
Investigations
Neutrophil count decreased
|
38.7%
46/119 • Number of events 59
|
|
Investigations
Pancreatic enzymes decreased
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Platelet count decreased
|
68.9%
82/119 • Number of events 119
|
|
Investigations
Serum cholesterol increased
|
1.7%
2/119 • Number of events 2
|
|
Investigations
Weight gain
|
1.7%
2/119 • Number of events 2
|
|
Investigations
Weight loss
|
11.8%
14/119 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia
|
25.2%
30/119 • Number of events 32
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.7%
2/119 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
35.3%
42/119 • Number of events 60
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
2/119 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.4%
4/119 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
23.5%
28/119 • Number of events 31
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
12.6%
15/119 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.2%
5/119 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
4.2%
5/119 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
6.7%
8/119 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
19.3%
23/119 • Number of events 28
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.2%
5/119 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
13.4%
16/119 • Number of events 21
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
10/119 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.2%
5/119 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
2.5%
3/119 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
4/119 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
4/119 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
3.4%
4/119 • Number of events 5
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Headache
|
13.4%
16/119 • Number of events 18
|
|
Nervous system disorders
Memory impairment
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.2%
5/119 • Number of events 6
|
|
Nervous system disorders
Taste alteration
|
26.9%
32/119 • Number of events 39
|
|
Nervous system disorders
Tremor
|
1.7%
2/119 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.7%
2/119 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
8.4%
10/119 • Number of events 11
|
|
Psychiatric disorders
Confusion
|
2.5%
3/119 • Number of events 3
|
|
Psychiatric disorders
Depression
|
5.0%
6/119 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
9.2%
11/119 • Number of events 12
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
5/119 • Number of events 5
|
|
Renal and urinary disorders
Urinary retention
|
0.84%
1/119 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
0.84%
1/119 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.84%
1/119 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal pain
|
1.7%
2/119 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.2%
5/119 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
6/119 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.8%
20/119 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
3.4%
4/119 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.5%
3/119 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.7%
2/119 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
5/119 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.2%
30/119 • Number of events 39
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.84%
1/119 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.84%
1/119 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.4%
35/119 • Number of events 42
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
66.4%
79/119 • Number of events 108
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
31.9%
38/119 • Number of events 43
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
5.0%
6/119 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.5%
3/119 • Number of events 4
|
|
Vascular disorders
Hot flashes
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Hypertension
|
9.2%
11/119 • Number of events 12
|
|
Vascular disorders
Hypotension
|
1.7%
2/119 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
2.5%
3/119 • Number of events 3
|
|
Vascular disorders
Thromboembolic event
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.5%
3/119 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60