Trial Outcomes & Findings for Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia (NCT NCT03844997)
NCT ID: NCT03844997
Last Updated: 2025-05-31
Results Overview
If Grade 3-4 non-hematologic toxicity is observed in 1 or less of 6 patients treated, the dose of the study drug will be considered safe/tolerable. If Grade 3-4 non-hematologic toxicity is observed in 2 or more of 6 patients treated, 6 additional patients will be treated on the Phase IIa portion at a lower dose level (100 mg po).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Between days 28-35 of starting treatment
Results posted on
2025-05-31
Participant Flow
Participant milestones
| Measure |
Phase I
Palbociclib was given at dose level 1 (75 mg po) on day -1 and -2, day 0 was rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) was started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
Patients received 1-2 induction courses of the combination of Palbociclib and 125mg of CPX-351.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
26
|
|
Overall Study
COMPLETED
|
9
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Phase I
n=9 Participants
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
n=26 Participants
Patients will receive 1-2 induction courses of the combination of Palbociclib and CPX-351.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
47 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
History of Cancer
No cancer
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
History of Cancer
AML
|
2 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
History of Cancer
MDS
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
History of Cancer
MPN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
History of Cancer
Other cancer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
AML(Acute Myeloid Leukemia) Classification
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
AML(Acute Myeloid Leukemia) Classification
AML not otherwise specified
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
AML(Acute Myeloid Leukemia) Classification
AML with certain genetic abnormalities
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
AML(Acute Myeloid Leukemia) Classification
AML with myelodysplasia-related changes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between days 28-35 of starting treatmentPopulation: Safety and tolerability only measured for Phase I
If Grade 3-4 non-hematologic toxicity is observed in 1 or less of 6 patients treated, the dose of the study drug will be considered safe/tolerable. If Grade 3-4 non-hematologic toxicity is observed in 2 or more of 6 patients treated, 6 additional patients will be treated on the Phase IIa portion at a lower dose level (100 mg po).
Outcome measures
| Measure |
Phase I
n=9 Participants
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Safety and Tolerability of Experimental Dose of Palbociclibin Combination With CPX-351 as Measured by Number of Participants With Dose Limiting Toxicities.
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 2 years from end of treatment, up to 27 monthsPopulation: ORR was measured only for Phase II
Efficacy of Palbociclibin combination with chemotherapy as measured by overall response rate (ORR) which is defined as complete response (CR) and CR with incomplete blood count recovery (CRi) by IWG criteria. Complete remission is defined as: Bone marrow blasts \<5%; absence ofcirculating blasts and blasts with Auerrods; absence of extramedullarydisease; absolute neutrophil count \>1.0x 109/L (1,000/μL); platelet count \>100 x109/L (100,000/μL) and CR with incomplete blood count recovery is defined as: All CR criteria except for residualneutropenia \[\<1.0 x 109/L (1,000/μL)\] orthrombocytopenia \[\<100 x 109/L(100,000/μL)\]. Either of these responses will constitute ORR.
Outcome measures
| Measure |
Phase I
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
n=26 Participants
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Efficacy of Palbociclibin Combination With Chemotherapy as Measured by Overall Response Rate (ORR).
|
—
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from end of treatmentTTR is defined as the time it takes from the start date of the treatment to the date of achievement of response (as per the definition of response mentioned in the 2003 IWG criteria).
Outcome measures
| Measure |
Phase I
n=6 Participants
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
n=22 Participants
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Time to Response (TTR)
|
43.37 Days
Interval 35.0 to 62.0
|
41.27 Days
Interval 33.0 to 103.0
|
SECONDARY outcome
Timeframe: Up to 2 years from end of treatmentDOR is measured between the date of response to date of loss of response.
Outcome measures
| Measure |
Phase I
n=6 Participants
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
n=22 Participants
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Duration of Response (DOR)
|
302.91 Days
Interval 119.0 to 720.0
|
523.7 Days
Interval 66.0 to 735.0
|
SECONDARY outcome
Timeframe: Up to 2 years from end of treatmentEFS measured from the date of entry into a study to the date of primary refractory disease, or relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined
Outcome measures
| Measure |
Phase I
n=9 Participants
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
n=26 Participants
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Event-free Survival (EFS)
|
188.23 Days
Interval 20.0 to 767.0
|
406.09 Days
Interval 42.0 to 787.0
|
SECONDARY outcome
Timeframe: Up to 2 years from end of treatment, up to 27 monthsOS probability measured from the date of entry into a clinical trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive
Outcome measures
| Measure |
Phase I
n=9 Participants
Palbociclib will be given at dose level 1 (75 mg po) on day -1 and -2, day 0 will be rest and then CPX-351 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) will be started on day 1, 3, and 5 along with Palbociclib on day 2, 4, and 6 followed by rest/monitoring period (days 7-35)
|
Phase II
n=26 Participants
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Overall Survival (OS) Probability
|
25 percentage of paticipants
|
76 percentage of paticipants
|
Adverse Events
Phase I
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Phase II
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I
n=9 participants at risk
Palbociclib was administered orally on day -1 and -2 at 125 mg PO during the phase IIaportion (dose level 0).Day 0 will be rest and then CPX-351 at 100 u/m2 will be started on days 1, 3, and 5 along with Palbociclib day 2, 4, and 6 followed by rest/monitoring period (day 7-28).
|
Phase II
n=26 participants at risk
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
Other adverse events
| Measure |
Phase I
n=9 participants at risk
Palbociclib was administered orally on day -1 and -2 at 125 mg PO during the phase IIaportion (dose level 0).Day 0 will be rest and then CPX-351 at 100 u/m2 will be started on days 1, 3, and 5 along with Palbociclib day 2, 4, and 6 followed by rest/monitoring period (day 7-28).
|
Phase II
n=26 participants at risk
Participants received 1-2 induction courses of the combination of Palbociclib and CPX-351
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Blurred vision
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
3/9 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
61.5%
16/26 • Number of events 42 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
55.6%
5/9 • Number of events 7 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
34.6%
9/26 • Number of events 17 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
9/9 • Number of events 66 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
76.9%
20/26 • Number of events 47 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
4/9 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
61.5%
16/26 • Number of events 43 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
26.9%
7/26 • Number of events 12 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Bacteremia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Bladder infection
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Blood bilirubin increased
|
22.2%
2/9 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
30.8%
8/26 • Number of events 14 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Cardiac troponin T increased
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Chest wall pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Chills
|
22.2%
2/9 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
26.9%
7/26 • Number of events 9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
46.2%
12/26 • Number of events 15 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
42.3%
11/26 • Number of events 15 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Creatinine increased
|
44.4%
4/9 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
30.8%
8/26 • Number of events 16 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Psychiatric disorders
Delirium
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
46.2%
12/26 • Number of events 14 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
2/9 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
30.8%
8/26 • Number of events 8 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Edema face
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Edema limbs
|
33.3%
3/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
42.3%
11/26 • Number of events 11 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
3/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
46.2%
12/26 • Number of events 14 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Esophageal pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Facial pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Fatigue
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
46.2%
12/26 • Number of events 13 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
55.6%
5/9 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
92.3%
24/26 • Number of events 36 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Fever
|
44.4%
4/9 • Number of events 10 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
22.2%
2/9 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Floaters
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Generalized edema
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Genital edema
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Headache
|
66.7%
6/9 • Number of events 7 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
53.8%
14/26 • Number of events 19 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 12 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
88.9%
8/9 • Number of events 12 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
46.2%
12/26 • Number of events 17 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
2/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
77.8%
7/9 • Number of events 9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
69.2%
18/26 • Number of events 33 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
2/9 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
6/9 • Number of events 8 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
53.8%
14/26 • Number of events 28 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
22.2%
2/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
53.8%
14/26 • Number of events 26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Hypotension
|
22.2%
2/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 8 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Injury, poisoning and procedural complications
Infusion site extravasation
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
INR increased
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Psychiatric disorders
Insomnia
|
33.3%
3/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
26.9%
7/26 • Number of events 7 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Localized edema
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
22.2%
2/9 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 8 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Menorrhagia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
42.3%
11/26 • Number of events 14 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Myocarditis
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Number of events 7 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
57.7%
15/26 • Number of events 20 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Neuralgia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Neutrophil count decreased
|
88.9%
8/9 • Number of events 19 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
50.0%
13/26 • Number of events 30 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
30.8%
8/26 • Number of events 12 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Oral hemorrhage
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Papulopustular rash
|
22.2%
2/9 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Phlebitis
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
Platelet count decreased
|
88.9%
8/9 • Number of events 38 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
88.5%
23/26 • Number of events 79 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
30.8%
8/26 • Number of events 11 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 5 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
3/9 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
80.8%
21/26 • Number of events 34 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Retinopathy
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Scleral disorder
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus bradycardia
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
19.2%
5/26 • Number of events 6 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
33.3%
3/9 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
38.5%
10/26 • Number of events 12 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
7.7%
2/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
11.5%
3/26 • Number of events 3 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Superficial thrombophlebitis
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Thrush
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Uveitis
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 2 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Vaginal discharge
|
11.1%
1/9 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
0.00%
0/26 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Vaginal infection
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
15.4%
4/26 • Number of events 4 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Eye disorders
Watering eyes
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
3.8%
1/26 • Number of events 1 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
|
Investigations
White blood cell decreased
|
100.0%
9/9 • Number of events 25 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
80.8%
21/26 • Number of events 67 • All adverse events were collected through 30 days after the final dose of study drug, up to 100 days, all cause mortality was assessed through 2 years from end of treatment
|
Additional Information
Sudipto Mukherjee, MD, PhD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Phone: 866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place