Trial Outcomes & Findings for Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer (NCT NCT02865811)
NCT ID: NCT02865811
Last Updated: 2022-09-13
Results Overview
The primary objective was to determine the CBR (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\] \>/= 24 weeks) of the combination of pembrolizumab and PLD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
24 Weeks
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Pembrolizumab in Combination With PLD
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab in Combination With PLD
n=26 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag
|
|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Age, Customized
|
60.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Stage at Initial Diagnosis
Stage I
|
2 Participants
n=5 Participants
|
|
Stage at Initial Diagnosis
Stage II
|
1 Participants
n=5 Participants
|
|
Stage at Initial Diagnosis
Stage III
|
12 Participants
n=5 Participants
|
|
Stage at Initial Diagnosis
Stage IV
|
10 Participants
n=5 Participants
|
|
Stage at Initial Diagnosis
Missing
|
1 Participants
n=5 Participants
|
|
Differentiation (Grade)
Well Differentiated
|
1 Participants
n=5 Participants
|
|
Differentiation (Grade)
Moderately Differentiated
|
1 Participants
n=5 Participants
|
|
Differentiation (Grade)
Poorly Differentiated
|
21 Participants
n=5 Participants
|
|
Differentiation (Grade)
Missing
|
3 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma, not further specified
|
1 Participants
n=5 Participants
|
|
Histology
Serous
|
20 Participants
n=5 Participants
|
|
Histology
Clear Cell
|
2 Participants
n=5 Participants
|
|
Histology
Mucinous
|
2 Participants
n=5 Participants
|
|
Histology
Mixed serous/mucinous
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status
0- Fully Active
|
16 Participants
n=5 Participants
|
|
ECOG Performance Status
1- Restricted
|
10 Participants
n=5 Participants
|
|
# of Prior Lines
1
|
10 Participants
n=5 Participants
|
|
# of Prior Lines
2
|
10 Participants
n=5 Participants
|
|
# of Prior Lines
3
|
6 Participants
n=5 Participants
|
|
Platinum Free Interval (PFI)
<3 Months
|
7 Participants
n=5 Participants
|
|
Platinum Free Interval (PFI)
3-6 Months
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Of the 26 patients enrolled, 23 patients were evaluable for objective response by RECIST.
The primary objective was to determine the CBR (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\] \>/= 24 weeks) of the combination of pembrolizumab and PLD.
Outcome measures
| Measure |
Pembrolizumab in Combination With PLD
n=23 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Pembrolizumab: Please see "Arms" for description.
Pegylated Liposomal Doxorubicin (PLD): Please see "Arms" for description.
|
|---|---|
|
Clinical Benefit Rate [CBR]
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 6 patients were included in the safety lead-in group
Safety is measured by any dose limiting toxicity experienced within the safety lead in group of 6 patients. If 2 out of the first 6 patients develop a DLT, the dose of PLD will be reduced to 30 mg/m2. If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD), an additional 20 patients will be enrolled to complete the phase II study.
Outcome measures
| Measure |
Pembrolizumab in Combination With PLD
n=6 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Pembrolizumab: Please see "Arms" for description.
Pegylated Liposomal Doxorubicin (PLD): Please see "Arms" for description.
|
|---|---|
|
Safety of the Combination of Pembrolizumab/PLD
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Of the 26 patients enrolled, 23 patients were evaluable for objective response by RECIST.
A secondary objective was to determine the Overall Response Rate \[ORR\] of the combination of pembrolizumab and PLD as defined by the number of participants achieving a partial response \[PR\] or complete response \[CR\].
Outcome measures
| Measure |
Pembrolizumab in Combination With PLD
n=23 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Pembrolizumab: Please see "Arms" for description.
Pegylated Liposomal Doxorubicin (PLD): Please see "Arms" for description.
|
|---|---|
|
Overall Response Rate [ORR]
Partial Response
|
5 Participants
|
|
Overall Response Rate [ORR]
Complete Reponse
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsThe duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Outcome measures
| Measure |
Pembrolizumab in Combination With PLD
n=26 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Pembrolizumab: Please see "Arms" for description.
Pegylated Liposomal Doxorubicin (PLD): Please see "Arms" for description.
|
|---|---|
|
Duration of Response [DOR]
|
10.58 months
Interval 2.56 to
There are not enough events to estimate the upper confidence limit for the duration of response, therefore the upper limit of the response curve hasn't reached 50% probability which is the median line.
|
SECONDARY outcome
Timeframe: 24 weeksProgression-Free Survival is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without progression are censored at date of last disease evaluation.
Outcome measures
| Measure |
Pembrolizumab in Combination With PLD
n=26 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Pembrolizumab: Please see "Arms" for description.
Pegylated Liposomal Doxorubicin (PLD): Please see "Arms" for description.
|
|---|---|
|
Progression-Free Survival [PFS]
Progression events defined by RECIST 1.1
|
8.1 months
Interval 1.7 to 14.7
|
|
Progression-Free Survival [PFS]
Progression events defined by RECIST 1.1 and clinical progression
|
5.6 months
Interval 1.7 to 10.1
|
SECONDARY outcome
Timeframe: 24 MonthsOverall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Outcome measures
| Measure |
Pembrolizumab in Combination With PLD
n=26 Participants
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Pembrolizumab: Please see "Arms" for description.
Pegylated Liposomal Doxorubicin (PLD): Please see "Arms" for description.
|
|---|---|
|
Overall Survival
|
18.3 months
Interval 9.4 to 31.5
|
Adverse Events
Pembrolizumab in Combination With PLD
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab in Combination With PLD
n=26 participants at risk
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • Number of events 2 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Alkaline phosphatase increased
|
3.8%
1/26 • Number of events 2 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Seizure
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
Other adverse events
| Measure |
Pembrolizumab in Combination With PLD
n=26 participants at risk
A safety lead in with 6 patients will be studied prior the start of the treatment.
* If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
* If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
* Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
* Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosag
|
|---|---|
|
General disorders
Fatigue
|
50.0%
13/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Abdominal pain
|
42.3%
11/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
10/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.5%
10/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Blood and lymphatic system disorders
Anemia
|
34.6%
9/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
8/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
30.8%
8/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Diarrhea
|
26.9%
7/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
26.9%
7/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
26.9%
7/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.9%
7/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.9%
7/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Dyspepsia
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Fever
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Pain
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Alanine aminotransferase increased
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Alkaline phosphatase increased
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Neutrophil count decreased
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Platelet count decreased
|
19.2%
5/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Mucositis oral
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Ascites
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
4/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Endocrine disorders
Hypothyroidism
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Oral pain
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Infusion related reaction
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Non-cardiac chest pain
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Upper respiratory infection
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Vascular disorders
Hypertension
|
11.5%
3/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Bloating
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Fecal incontinence
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Edema limbs
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Skin infection
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Blood bilirubin increased
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Creatinine increased
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Psychiatric disorders
Confusion
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Renal and urinary disorders
Urinary urgency
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Mucosal infection
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Reproductive system and breast disorders
Pneumonitis
|
7.7%
2/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Endocrine disorders
Hyperthyroidism
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Eye disorders
Dry eye
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Gastroparesis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
Chills
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Immune system disorders
Allergic reaction
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Paresthesia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Cardiac disorders
Sinus tachycardia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Vaginal infection
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Lymphocyte count decreased
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Investigations
Weight loss
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Renal and urinary disorders
Bladder spasm
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Vascular disorders
Thromboembolic event
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
|
Nervous system disorders
Seizure
|
3.8%
1/26 • Adverse Events (AEs) were collected weekly throughout study participation for all patients, and for 4 weeks after treatment completion.
Expedited reporting applied to any medical event equivalent to an unexpected grade 2 or 3 with a possible, probable or definite attribution, both expected (unless listed in the protocol as not requiring expedited reporting) and unexpected grade 4 toxicities, and grade 5 (death) regardless of study phase or attribution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place