Trial Outcomes & Findings for Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer (NCT NCT00577889)
NCT ID: NCT00577889
Last Updated: 2014-07-25
Results Overview
A patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2014-07-25
Participant Flow
A total of 21 patients were accrued from May 30, 2008 to September 2, 2010.
A total of 21 patients were accrued and randomized onto one of 3 parallel arms (Arm I: 9 patients; Arm II: 6 patients; Arm III: 6 patients). One patient from Arm I canceled and was not used in baseline analysis nor endpoint analysis.
Participant milestones
| Measure |
Arm I (Combination Chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Combination Chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Combination Chemotherapy)
n=8 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
71 years
n=7 Participants
|
67 years
n=5 Participants
|
61.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy)
n=8 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Six Month Survival Rate
|
25 percentage of patients
Interval 7.5 to 83.0
|
67 percentage of patients
Interval 38.0 to 100.0
|
33 percentage of patients
Interval 11.0 to 100.0
|
SECONDARY outcome
Timeframe: Assessed up to 2 years from registrationOverall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy)
n=8 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Overall Survival Time
|
4.8 months
Interval 2.8 to 6.6
|
6.9 months
Interval 2.4 to 10.7
|
4.3 months
Interval 1.9 to 15.3
|
SECONDARY outcome
Timeframe: Time from registration to documentation of disease progression, assessed up to 2 yearsThe time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA). Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy)
n=8 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Time to Disease Progression
|
2.2 months
Interval 1.4 to 4.0
|
4.1 months
Interval 1.4 to 7.9
|
2.3 months
Interval 1.4 to 4.0
|
SECONDARY outcome
Timeframe: 2 consecutive evaluations at least 4 weeks, up to 6 courses of treatmentA confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA). Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy)
n=8 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 Participants
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Confirmed Response Rate
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Arm I (Combination Chemotherapy)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm II (Combination Chemotherapy)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm III (Combination Chemotherapy)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Combination Chemotherapy)
n=8 participants at risk
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 participants at risk
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 participants at risk
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Infection
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Hematoma
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Thrombosis
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
Other adverse events
| Measure |
Arm I (Combination Chemotherapy)
n=8 participants at risk
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm II (Combination Chemotherapy)
n=6 participants at risk
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
Arm III (Combination Chemotherapy)
n=6 participants at risk
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
87.5%
7/8 • Number of events 22
|
66.7%
4/6 • Number of events 15
|
100.0%
6/6 • Number of events 16
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
6/8 • Number of events 13
|
83.3%
5/6 • Number of events 9
|
83.3%
5/6 • Number of events 10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Gastric mucositis
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 16
|
66.7%
4/6 • Number of events 8
|
83.3%
5/6 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 8
|
50.0%
3/6 • Number of events 4
|
50.0%
3/6 • Number of events 5
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
87.5%
7/8 • Number of events 24
|
83.3%
5/6 • Number of events 16
|
83.3%
5/6 • Number of events 15
|
|
General disorders
General symptom
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
4/8 • Number of events 6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
4/8 • Number of events 11
|
33.3%
2/6 • Number of events 9
|
33.3%
2/6 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Investigations
Bilirubin increased
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Leukocyte count decreased
|
50.0%
4/8 • Number of events 12
|
33.3%
2/6 • Number of events 3
|
50.0%
3/6 • Number of events 6
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8 • Number of events 6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
50.0%
4/8 • Number of events 7
|
66.7%
4/6 • Number of events 8
|
33.3%
2/6 • Number of events 5
|
|
Investigations
Platelet count decreased
|
37.5%
3/8 • Number of events 7
|
33.3%
2/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • Number of events 5
|
0.00%
0/6
|
33.3%
2/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
37.5%
3/8 • Number of events 7
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
25.0%
2/8 • Number of events 5
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/8
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/8
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
25.0%
2/8 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 4
|
0.00%
0/6
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60