Trial Outcomes & Findings for Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma (NCT NCT01879085)
NCT ID: NCT01879085
Last Updated: 2022-09-21
Results Overview
Recommended Phase ll dose of vorinostat that can be safely combined with gemcitabine and docetaxel. Gemcitabine and docetaxel were given at a fixed dose while vorinostat was dose-escalated using a standard '3+3' design. Dose-limiting toxicity (DLT) is defined as specific study drug-related events experienced during Cycle 1; only DLTs observed in a patient during the first cycle of treatment will be used for the dose escalation decision.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
During Cycle 1 of treatment
Results posted on
2022-09-21
Participant Flow
Analysis of Phase 2 group includes (6) patients who enrolled to the Phase 1b group at Dose Level 1.
Participant milestones
| Measure |
Dose Level 1
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at Dose level 1 (300 mg/day) on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
Dose Level 2
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at Dose level 2 (200 mg twice/day) on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
Phase 2
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at Dose level 1 (300 mg/day) on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|---|---|
|
Phase 1b
STARTED
|
6
|
6
|
0
|
|
Phase 1b
COMPLETED
|
6
|
6
|
0
|
|
Phase 1b
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
6
|
0
|
25
|
|
Phase 2
COMPLETED
|
6
|
0
|
25
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=31 Participants
Dose Level 1:
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).
Vorinostat: 300 mg daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
Dose Level 2
n=6 Participants
Dose Level 2:
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).
Vorinostat: 200 mg twice daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.68 years
STANDARD_DEVIATION 15.16 • n=5 Participants
|
50.50 years
STANDARD_DEVIATION 17.03 • n=7 Participants
|
55.03 years
STANDARD_DEVIATION 15.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During Cycle 1 of treatmentPopulation: Patients treated with combination therapy.
Recommended Phase ll dose of vorinostat that can be safely combined with gemcitabine and docetaxel. Gemcitabine and docetaxel were given at a fixed dose while vorinostat was dose-escalated using a standard '3+3' design. Dose-limiting toxicity (DLT) is defined as specific study drug-related events experienced during Cycle 1; only DLTs observed in a patient during the first cycle of treatment will be used for the dose escalation decision.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=12 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
Phase I: Recommended Phase II Dose of Vorinostat
|
300 mg/day of Vorinostat
|
PRIMARY outcome
Timeframe: Up to 6 months (per patient)Population: Patients that received combination therapy that were evaluable for response to treatment. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
Proportion of participants whose disease does not progress within 6 months of start of treatment (number of patients without progressive disease/total number of patients). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
Six-month Progression-free Survival (PFS)
|
0.473 proportion of participants
Interval 0.325 to 0.69
|
SECONDARY outcome
Timeframe: Up to 7 years and 7 monthsPopulation: Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
Number of patients with Complete response \[CR\] + partial response \[PR\], per RECIST v1.1 criteria . Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
Objective Response Rate (ORR)
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 7 years and 7 monthsPopulation: Patients that received combination therapy that were evaluable for response to treatment. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
The median length of time from the beginning of study treatment that patients remain alive without progression of their disease (cancer). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
Progression-free Survival (PFS)
|
5.552361 months
Interval 2.694045 to 12.41889
|
SECONDARY outcome
Timeframe: Up to one year (per patient)Population: Patients that received combination therapy that were evaluable for response to treatment. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
Proportion of participants whose disease does not progress within one year of start of treatment (number of patients with progressive disease/total number of patients). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
One-year Progression-free Survival (PFS)
|
0.304 proportion of participants
Interval 0.177 to 0.523
|
SECONDARY outcome
Timeframe: Up to 7 years and 7 monthsPopulation: Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
The median length of time from the start of treatment that diagnosed study participants remain alive.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
Overall Survival (OS)
|
11.92608 months
Interval 10.05339 to 20.33676
|
SECONDARY outcome
Timeframe: Up to 6 months (per patient)Population: Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
Proportion of participants alive at six months from the start of treatment.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
Six-month Overall Survival (OS)
|
0.742 proportion of participants
Interval 0.603 to 0.913
|
SECONDARY outcome
Timeframe: Up to one year (per patient)Population: Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
Proportion of participants alive at one year from the start of treatment.
Outcome measures
| Measure |
Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim
n=31 Participants
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
Vorinostat: given orally at either 300 mg/day, on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|
|
One-year Overall Survival (OS)
|
0.477 proportion of participants
Interval 0.328 to 0.692
|
Adverse Events
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day
Serious events: 19 serious events
Other events: 31 other events
Deaths: 26 deaths
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day
n=31 participants at risk
Dose Level 1:
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).
Vorinostat: 300 mg daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day
n=6 participants at risk
Dose Level 2:
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).
Vorinostat: 200 mg twice daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Fever
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Cardiac disorders
Heart failure
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Investigations - Other, specify
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Malaise
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Neutrophil count decreased
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Skin infection
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Superior vena cava syndrome
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Edema limbs
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Fatigue
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Uspecified
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Pain
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
Other adverse events
| Measure |
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day
n=31 participants at risk
Dose Level 1:
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).
Vorinostat: 300 mg daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day
n=6 participants at risk
Dose Level 2:
Docetaxel: 75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
Gemcitabine: given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle).
Vorinostat: 200 mg twice daily given orally on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
Pegfilgrastim: Administered on day 9 subcutaneously at 6 mg.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Alanine aminotransferase increased
|
32.3%
10/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Alkaline phosphatase increased
|
61.3%
19/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
32.3%
10/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Blood and lymphatic system disorders
Anemia
|
96.8%
30/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
100.0%
6/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Anorexia
|
41.9%
13/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Psychiatric disorders
Anxiety
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Aspartate aminotransferase increased
|
38.7%
12/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Bloating
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
32.3%
10/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Blood bilirubin increased
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
22.6%
7/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Chills
|
16.1%
5/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Cholesterol high
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Eye disorders
Conjunctivitis
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Constipation
|
58.1%
18/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
48.4%
15/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Creatinine increased
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Psychiatric disorders
Delirium
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Dental caries
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Psychiatric disorders
Depression
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
66.7%
4/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Diarrhea
|
51.6%
16/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Eye disorders
Dry eye
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Dry mouth
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.6%
7/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Dysesthesia
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Dysgeusia
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
45.2%
14/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Edema face
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Edema limbs
|
54.8%
17/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Esophagitis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Eye disorders
Eyelid function disorder
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Fatigue
|
71.0%
22/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
66.7%
4/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Fever
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Flu like symptoms
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Flushing
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Gait disturbance
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
29.0%
9/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
38.7%
12/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Headache
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Renal and urinary disorders
Hematuria
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.6%
7/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
22.6%
7/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Hypertension
|
51.6%
16/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
83.9%
26/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
54.8%
17/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
58.1%
18/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
32.3%
10/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
83.9%
26/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
100.0%
6/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Endocrine disorders
Hypoparathyroidism
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
48.4%
15/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
83.3%
5/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Hypotension
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
83.3%
5/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
INR increased
|
16.1%
5/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Psychiatric disorders
Insomnia
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Investigations - Other, specify
|
96.8%
30/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
83.3%
5/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Localized edema
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Lymphedema
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Lymphocyte count decreased
|
83.9%
26/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
83.3%
5/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Lymphocyte count increased
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Malaise
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Memory impairment
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
32.3%
10/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Movements involuntary
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Mucosal infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Mucositis oral
|
22.6%
7/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
22.6%
7/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.1%
5/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Nausea
|
71.0%
22/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Neutrophil count decreased
|
54.8%
17/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Metabolism and nutrition disorders
Obesity
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Otitis externa
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
General disorders
Pain
|
58.1%
18/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
50.0%
3/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Pancreatic enzymes decreased
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Paresthesia
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Platelet count decreased
|
87.1%
27/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
100.0%
6/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.4%
6/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Rash pustular
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
16.1%
5/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
29.0%
9/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Cardiac disorders
Sinus tachycardia
|
45.2%
14/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
41.9%
13/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Stomach pain
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Superficial thrombophlebitis
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Superior vena cava syndrome
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Thromboembolic event
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Nervous system disorders
Tremor
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Upper respiratory infection
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Renal and urinary disorders
Urinary frequency
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Infections and infestations
Vaginal infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Gastrointestinal disorders
Vomiting
|
25.8%
8/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Weight gain
|
6.5%
2/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
Weight loss
|
12.9%
4/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Investigations
White blood cell decreased
|
64.5%
20/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
33.3%
2/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
3.2%
1/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
0.00%
0/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
|
Psychiatric disorders
Personality Change
|
0.00%
0/31 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
16.7%
1/6 • Both Adverse Events and All-Cause Mortality were assess continuously over a duration of time up to 7 years and 7 months (for the population).
Additional information: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat.
|
Additional Information
Barbara M Stadterman, MPH, MCCR, Clinical Trials Administrator
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place