Trial Outcomes & Findings for Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients (NCT NCT00038142)
NCT ID: NCT00038142
Last Updated: 2020-01-29
Results Overview
DFS defined as survival of participants to two years post study entry without relapse.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
2 years
Results posted on
2020-01-29
Participant Flow
Recruitment Period: November 13, 1997 to December 7, 2009. Recruitment was done within medical clinic settings.
Study closed early with low recruitment due to the sponsor going out of business therefore drug no longer manufactured.
Participant milestones
| Measure |
Arm A: VACdxr With ImmTher
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week for 50-52 weeks.
|
Arm B: VACdxr
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
14
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
22
|
7
|
Reasons for withdrawal
| Measure |
Arm A: VACdxr With ImmTher
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week for 50-52 weeks.
|
Arm B: VACdxr
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).
|
|---|---|---|
|
Overall Study
Ineligible
|
1
|
0
|
|
Overall Study
Progressive Disease
|
11
|
7
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Unknown Reason
|
8
|
0
|
Baseline Characteristics
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients
Baseline characteristics by cohort
| Measure |
Arm A: VACdxr With ImmTher
n=32 Participants
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week for 50-52 weeks.
|
Arm B: VACdxr
n=14 Participants
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 years
n=39 Participants
|
17 years
n=41 Participants
|
16 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=39 Participants
|
14 participants
n=41 Participants
|
46 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data was not collected due to early termination of the protocol
DFS defined as survival of participants to two years post study entry without relapse.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: VACdxr With ImmTher
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Arm B: VACdxr
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: VACdxr With ImmTher
n=31 participants at risk
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week for 50-52 weeks.
|
Arm B: VACdxr
n=14 participants at risk
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
Other adverse events
| Measure |
Arm A: VACdxr With ImmTher
n=31 participants at risk
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week for 50-52 weeks.
|
Arm B: VACdxr
n=14 participants at risk
Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).
|
|---|---|---|
|
Gastrointestinal disorders
Abdomen Pain
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Abdominal Cramping
|
0.00%
0/31 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.0%
9/31 • Number of events 9 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
42.9%
6/14 • Number of events 6 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Investigations
Alanine Aminotransferase/ Serum Glutamic Pyruvic Transamnase
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Investigations
Amylase Increase
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
74.2%
23/31 • Number of events 23 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
71.4%
10/14 • Number of events 10 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.6%
7/31 • Number of events 7 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
21.4%
3/14 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Atrophy, Subcutaneious
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Investigations
Bleed Platelets Grade 3, 4
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Eye disorders
Blurred Vision
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Candidiasis
|
0.00%
0/31 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Cardiac Function
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Cardiaovascular General
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Chest Pain
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Constipation
|
35.5%
11/31 • Number of events 11 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
28.6%
4/14 • Number of events 4 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
41.9%
13/31 • Number of events 13 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
42.9%
6/14 • Number of events 6 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Drug Fever
|
38.7%
12/31 • Number of events 12 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Renal and urinary disorders
Dysuria
|
9.7%
3/31 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Edema
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Fatigue
|
41.9%
13/31 • Number of events 13 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Investigations
Fever Neutropenic
|
54.8%
17/31 • Number of events 17 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
57.1%
8/14 • Number of events 8 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Fever Unknown Origin
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Fever Without Neutropenia
|
12.9%
4/31 • Number of events 4 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
28.6%
4/14 • Number of events 4 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
64.5%
20/31 • Number of events 20 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
71.4%
10/14 • Number of events 10 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Headache
|
61.3%
19/31 • Number of events 19 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
21.4%
3/14 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Renal and urinary disorders
Hematuria
|
9.7%
3/31 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
14.3%
2/14 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Reproductive system and breast disorders
Hot Flashes
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/31 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Vascular disorders
Hypotension
|
9.7%
3/31 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Infections and infestations
Infection
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Infections and infestations
Infection Neutropenia
|
12.9%
4/31 • Number of events 4 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Infections and infestations
Infection Without Neutropenia
|
0.00%
0/31 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Reproductive system and breast disorders
Irregular Menses
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
71.0%
22/31 • Number of events 22 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
71.4%
10/14 • Number of events 10 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Psychiatric disorders
Mood Alteration
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Mucositis
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Mucositis (Clinical assessment)
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
19.4%
6/31 • Number of events 6 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Nausea Alone
|
71.0%
22/31 • Number of events 22 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
64.3%
9/14 • Number of events 9 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Neuropathy: Motor
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Neuropathy: Sensor
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Ear and labyrinth disorders
Otitis, Middle Ear
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
6.5%
2/31 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Pain (Nos)
|
9.7%
3/31 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Pain, Other
|
22.6%
7/31 • Number of events 7 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Pain Neuropathic
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain, Back Other
|
12.9%
4/31 • Number of events 4 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Palpitations
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Blood and lymphatic system disorders
Platelete Increase
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
General disorders
Rigors, Chills
|
61.3%
19/31 • Number of events 19 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Sensory neuropathy
|
9.7%
3/31 • Number of events 3 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
12.9%
4/31 • Number of events 4 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
7.1%
1/14 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
45.2%
14/31 • Number of events 14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
14.3%
2/14 • Number of events 2 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Vascular disorders
Thrombocytopenia
|
74.2%
23/31 • Number of events 23 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
71.4%
10/14 • Number of events 10 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Nervous system disorders
Tremors
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Metabolism and nutrition disorders
Triglyceride, Serum Increase
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Typhlitis
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Renal and urinary disorders
Urinary Retention
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Reproductive system and breast disorders
Vaginal Mucositis
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Cardiac disorders
Ventricular Tachycardia
|
3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
|
Gastrointestinal disorders
Vomiting
|
67.7%
21/31 • Number of events 21 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
|
71.4%
10/14 • Number of events 10 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
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Investigations
Weight Loss
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3.2%
1/31 • Number of events 1 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
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0.00%
0/14 • Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.
One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.
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Additional Information
Dr. Eugenie S. Kleinerman, Professor, Pediatrics - Research
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-8110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place