Trial Outcomes & Findings for Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer (NCT NCT00002931)
NCT ID: NCT00002931
Last Updated: 2017-02-23
Results Overview
Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Until disease progression, up to 5 years.
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
HD Chemo and Auto Stem Cells
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
HD Chemo and Auto Stem Cells
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
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|---|---|
|
Overall Study
rapidly progressing disease during
|
2
|
Baseline Characteristics
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
Baseline characteristics by cohort
| Measure |
HD Chemo and Auto Stem Cells
n=48 Participants
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
|
|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
|
Gender
Male
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, up to 5 years.Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.
Outcome measures
| Measure |
HD Chemo and Auto Stem Cells
n=48 Participants
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
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|---|---|
|
Progression-free Survival
|
11.8 Months
Interval 5.8 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
PRIMARY outcome
Timeframe: From date of randomization until death of any cause, assessed up to 12 weeksNumber of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy
Outcome measures
| Measure |
HD Chemo and Auto Stem Cells
n=48 Participants
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
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|---|---|
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Toxic Effects
Hyperglycemia
|
4 participants
|
|
Toxic Effects
Transaminase alone
|
6 participants
|
|
Toxic Effects
Mucositis/stomatitis
|
10 participants
|
|
Toxic Effects
Nausea/vomiting
|
5 participants
|
|
Toxic Effects
Febrile neutropenia
|
1 participants
|
|
Toxic Effects
Diarrhea
|
3 participants
|
|
Toxic Effects
Hyperbilirubinemia
|
3 participants
|
|
Toxic Effects
Fever w/o neutropenia
|
2 participants
|
|
Toxic Effects
Hypocalcemia
|
2 participants
|
|
Toxic Effects
Hemorrhage
|
1 participants
|
|
Toxic Effects
Elevated INR/Prothrombin time
|
2 participants
|
|
Toxic Effects
Renal Failure
|
1 participants
|
|
Toxic Effects
Constipation
|
1 participants
|
|
Toxic Effects
Esophagitis
|
1 participants
|
SECONDARY outcome
Timeframe: Until death from any cause, up to 5 years.Estimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
HD Chemo and Auto Stem Cells
n=48 Participants
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
|
|---|---|
|
Overall Survival
|
21.7 Months
Interval 12.7 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
Adverse Events
HD Chemo and Auto Stem Cells
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HD Chemo and Auto Stem Cells
n=48 participants at risk
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
|
|---|---|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
HD Chemo and Auto Stem Cells
n=48 participants at risk
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
|
|---|---|
|
Nervous system disorders
Cerebellar
|
31.2%
15/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Clinical (Physical Exam)
|
27.1%
13/48 • Number of events 20 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Dysrhythmias
|
18.8%
9/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fluid Retention
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hematemesis
|
6.2%
3/48 • Number of events 4 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Ischemia
|
18.8%
9/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Other Misc
|
29.2%
14/48 • Number of events 57 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial
|
18.8%
9/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation associated with GVHD for BMT studies
|
8.3%
4/48 • Number of events 5 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Weight (Food Intake)
|
14.6%
7/48 • Number of events 12 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Clinical Coagulation
|
20.8%
10/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
|
25.0%
12/48 • Number of events 19 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
EF/CHF
|
18.8%
9/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
39.6%
19/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
6.2%
3/48 • Number of events 6 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing
|
33.3%
16/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
2.1%
1/48 • Number of events 4 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
6.2%
3/48 • Number of events 3 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision
|
33.3%
16/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision-blurred vision
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
58.3%
28/48 • Number of events 39 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
85.4%
41/48 • Number of events 64 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea patients with a colostomy
|
4.2%
2/48 • Number of events 4 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
4.2%
2/48 • Number of events 3 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
16.7%
8/48 • Number of events 9 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Incontinence
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
6.2%
3/48 • Number of events 4 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
60.4%
29/48 • Number of events 45 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
95.8%
46/48 • Number of events 74 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Proctitis
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
91.7%
44/48 • Number of events 73 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema
|
31.2%
15/48 • Number of events 16 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
37.5%
18/48 • Number of events 26 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever (no infection)
|
31.2%
15/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction/extravasation changes
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain - Other (Specify, __)
|
22.9%
11/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Rigors/chills
|
35.4%
17/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Allergy
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with ANC <1.0 x 10e9/L
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection with unknown ANC
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection without neutropenia
|
6.2%
3/48 • Number of events 4 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
AGC
|
33.3%
16/48 • Number of events 25 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
56.2%
27/48 • Number of events 42 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
56.2%
27/48 • Number of events 43 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline Phosphatase
|
27.1%
13/48 • Number of events 20 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase
|
39.6%
19/48 • Number of events 24 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Amylase
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin
|
27.1%
13/48 • Number of events 20 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
25.0%
12/48 • Number of events 15 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine
|
54.2%
26/48 • Number of events 36 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
HGB/HCT
|
8.3%
4/48 • Number of events 5 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
50.0%
24/48 • Number of events 38 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophils (ANC) (Somlo COH)
|
14.6%
7/48 • Number of events 11 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
47.9%
23/48 • Number of events 39 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
33.3%
16/48 • Number of events 23 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Partial Thromboplastin Time
|
20.8%
10/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelets
|
79.2%
38/48 • Number of events 61 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelets (Somlo COH)
|
14.6%
7/48 • Number of events 11 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Prothrombin Time
|
20.8%
10/48 • Number of events 13 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
SGOT/SGT
|
27.1%
13/48 • Number of events 20 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
WBC
|
10.4%
5/48 • Number of events 7 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
6.2%
3/48 • Number of events 5 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.1%
13/48 • Number of events 16 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.2%
3/48 • Number of events 3 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
60.4%
29/48 • Number of events 42 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
62.5%
30/48 • Number of events 46 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
29.2%
14/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.2%
15/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
29.2%
14/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
31.2%
15/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.2%
15/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
54.2%
26/48 • Number of events 39 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
4.2%
2/48 • Number of events 3 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.1%
1/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Cortical/State of Consciousness
|
33.3%
16/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
8/48 • Number of events 9 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
8.3%
4/48 • Number of events 4 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
33.3%
16/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Motor Activity
|
31.2%
15/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuropathy: motor
|
39.6%
19/48 • Number of events 24 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
52.1%
25/48 • Number of events 37 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral Nervous System Sensory
|
31.2%
15/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Seizure
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
12.5%
6/48 • Number of events 6 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Syncope (fainting)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
10.4%
5/48 • Number of events 5 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Hallucinations
|
6.2%
3/48 • Number of events 3 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Ideation
|
33.3%
16/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
33.3%
16/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Mood
|
33.3%
16/48 • Number of events 22 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Mood alteration
|
37.5%
18/48 • Number of events 21 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria
|
20.8%
10/48 • Number of events 15 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
10.4%
5/48 • Number of events 6 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Pain
|
45.8%
22/48 • Number of events 72 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
22.9%
11/48 • Number of events 16 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
7/48 • Number of events 7 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.4%
5/48 • Number of events 5 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.2%
3/48 • Number of events 3 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
14.6%
7/48 • Number of events 7 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
22.9%
11/48 • Number of events 16 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
20.8%
10/48 • Number of events 15 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Extensive Skin Rash
|
27.1%
13/48 • Number of events 19 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Local Skin Rash
|
27.1%
13/48 • Number of events 19 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
35.4%
17/48 • Number of events 24 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
4.2%
2/48 • Number of events 2 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Acute vascular leak syndrome
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
2.1%
1/48 • Number of events 1 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
18.8%
9/48 • Number of events 11 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
27.1%
13/48 • Number of events 17 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
39.6%
19/48 • Number of events 23 • Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place