Trial Outcomes & Findings for Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC (NCT NCT05057247)

NCT ID: NCT05057247

Last Updated: 2025-10-31

Results Overview

BOR rate was defined as the proportion of participants that experienced complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: Median time on treatment was 2.3 months (range 0.7-21.9 months)
• Results posted on: 2025-10-31

Participant Flow

Patients were enrolled from Octorber 14, 2021 to October 10, 2023.

Participant milestones

Measure	Duvelisib Plus Docetaxel Chemotherapy Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.
Overall Study STARTED	26
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Measure	Duvelisib Plus Docetaxel Chemotherapy Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.
Overall Study Death	4
Overall Study Physician Decision	3
Overall Study Progressive Disease	7
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	6
Overall Study Subject Non-Compliance	1
Overall Study On treatment	2

Baseline Characteristics

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

Baseline characteristics by cohort

Measure	Duvelisib Plus Docetaxel Chemotherapy n=26 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.
Age, Continuous	62.6 Years STANDARD_DEVIATION 64.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
ECOG Performance Status 0	11 Participants n=5 Participants
ECOG Performance Status 1	15 Participants n=5 Participants
PD-L1 Status (pre-treatment) Negative (CPS 0 to <1)	2 Participants n=5 Participants
PD-L1 Status (pre-treatment) Positive (CPS 1 or greater)	22 Participants n=5 Participants
PD-L1 Status (pre-treatment) Unknown	2 Participants n=5 Participants
TP53 status (pre-treatment) Mutated	10 Participants n=5 Participants
TP53 status (pre-treatment) Negative	16 Participants n=5 Participants
PI3K statue (Pre-treatment） Negative	19 Participants n=5 Participants
PI3K statue (Pre-treatment） Positive	7 Participants n=5 Participants
Primary Disease Site at Initial Diagnosis Hypopharynx	2 Participants n=5 Participants
Primary Disease Site at Initial Diagnosis Larynx	1 Participants n=5 Participants
Primary Disease Site at Initial Diagnosis Oral Cavity	11 Participants n=5 Participants
Primary Disease Site at Initial Diagnosis Oropharynx	12 Participants n=5 Participants
Site of recurrence prior to registration Locoregional	6 Participants n=5 Participants
Site of recurrence prior to registration Distant	10 Participants n=5 Participants
Site of recurrence prior to registration Both	10 Participants n=5 Participants
HPV status Negative	12 Participants n=5 Participants
HPV status Positive	14 Participants n=5 Participants
Smoking History No	8 Participants n=5 Participants
Smoking History Yes	18 Participants n=5 Participants
Current Smoker No	18 Participants n=5 Participants
Current Smoker Yes	3 Participants n=5 Participants
Current Smoker Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Median time on treatment was 2.3 months (range 0.7-21.9 months)

BOR rate was defined as the proportion of participants that experienced complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Outcome measures

Measure

Duvelisib Plus Docetaxel Chemotherapy n=26 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.

Best Overall Response (BOR) Rate

0.19 proportion of participants Interval 0.068 to 0.41

SECONDARY outcome

Timeframe: The median follow-up time was 6.5 months (range 0.7 - 26 months).

OS based on the Kaplan-Meier method was defined as the time from registration to death due to any cause, or censored at date last known alive.

Outcome measures

Measure

Duvelisib Plus Docetaxel Chemotherapy n=26 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.

Median Overall Survival (OS)

10.2 Months Interval 6.7 to 15.9

SECONDARY outcome

Timeframe: Median follow-up time was 2.3 months (range 0.7-21.9 months)

PFS based on the Kaplan-Meier method was defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Measure

Duvelisib Plus Docetaxel Chemotherapy n=26 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.

Median Progression Free Survival (PFS)

2.8 Months Interval 1.9 to 7.0

SECONDARY outcome

Timeframe: Median follow-up time was 2.3 months (range 0.7-21.9 months)

Population: Only participants who have responded to the treatment were included in the analysis.

DOR was measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure

Duvelisib Plus Docetaxel Chemotherapy n=5 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.

Duration of Response (DOR)

5.1 Months Interval 0.7 to 15.5

SECONDARY outcome

Timeframe: Median follow-up time was 2.3 months (range 0.7-21.9 months)

The number of participants who experienced the treatment-related adverse events per CTCAE 5.0 during the time of treatment.

Outcome measures

Measure

Duvelisib Plus Docetaxel Chemotherapy n=26 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.

Number of Participants With Treatment Related Adverse Events Per CTCAE 5.0

25 Participants

SECONDARY outcome

Timeframe: Up to 3 months

Population: The analysis population included the patients who answered at least some questions at both cycle 1 day 1 and cycle 4 day 1.

The QLQ H&N35 incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. The score range from 0 to 100.

For all items and scales, high scores indicate more problems, so negative difference indicates better QoL (less problems) at C4D1 compared to C1D1.

Outcome measures

Measure	Duvelisib Plus Docetaxel Chemotherapy n=11 Participants Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Pain	-3.8 Units on a scale Interval -25.0 to 16.7
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Swallowing	-1 Units on a scale Interval -25.0 to 30.6
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Senses problems	7.6 Units on a scale Interval -16.7 to 50.0
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Trouble with social eating	0.76 Units on a scale Interval -16.7 to 16.7
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Trouble with social contact	-1.2 Units on a scale Interval -20.0 to 13.3
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Less sexuality	6.1 Units on a scale Interval 0.0 to 33.3
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Teeth	-6.1 Units on a scale Interval -33.3 to 0.0
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Opening mouth	9.1 Units on a scale Interval -33.3 to 33.3
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Dry mouth	60.6 Units on a scale Interval 0.0 to 100.0
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Sticky saliva	-6.7 Units on a scale Interval -33.3 to 0.0
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Coughing	9.1 Units on a scale Interval -33.3 to 33.3
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Felt ill	0 Units on a scale Interval -33.3 to 33.3
Change of QLQ H&N 35 From Cycle 1 to Cycle 4 Speech problems	4.5 Units on a scale Interval -11.1 to 50.0

Adverse Events

Duvelisib Plus Docetaxel Chemotherapy

Serious events: 10 serious events

Other events: 26 other events

Deaths: 17 deaths

Serious adverse events

Measure	Duvelisib Plus Docetaxel Chemotherapy n=26 participants at risk Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.
Cardiac disorders Cardiac arrest	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Dysphagia	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Enterocolitis	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Gastric hemorrhage	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Nausea	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Edema face	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Fever	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders General disorders and administration site conditions - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Infections and infestations - Other, specify	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Lung infection	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Skin infection	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Thrush	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Viremia	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Injury, poisoning and procedural complications Fall	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Alanine aminotransferase increased	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Neutrophil count decreased	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Weight loss	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hyperlipidemia	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Nervous system disorders - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Renal and urinary disorders Acute kidney injury	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Aspiration	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Sore throat	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Vascular disorders Thromboembolic event	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.

Other adverse events

Measure	Duvelisib Plus Docetaxel Chemotherapy n=26 participants at risk Patients received duvelisib at the same dose of 25mg orally twice daily on days 1 through 21. Docetaxel was administered intravenously (IV) at a dose of 75 mg/m2 on day 1 of a 21-day cycle. Treatment duration is planned for 24 months (or longer if patient exhibits good tolerance and clinical benefit), unless unacceptable toxicity, disease progression, or withdrawl of consent occurs. Following the first 21-day cycle of therapy, both duvelisib and docetaxel are to be continued concurrently in 21-day subsequent cycles.
Blood and lymphatic system disorders Anemia	100.0% 26/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Blood and lymphatic system disorders Lymph node pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Cardiac disorders Cardiac disorders - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Cardiac disorders Conduction disorder	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Cardiac disorders Pericardial effusion	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Ear and labyrinth disorders Ear pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Ear and labyrinth disorders Hearing impaired	26.9% 7/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Ear and labyrinth disorders Tinnitus	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Endocrine disorders Endocrine disorders - Other, specify	23.1% 6/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Endocrine disorders Hypothyroidism	65.4% 17/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Endocrine disorders Testosterone deficiency	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Eye disorders Dry eye	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Eye disorders Eye disorders - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Eye disorders Periorbital edema	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Abdominal distension	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Abdominal pain	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Constipation	46.2% 12/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Dental caries	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Diarrhea	57.7% 15/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Dry mouth	57.7% 15/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Dyspepsia	23.1% 6/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Dysphagia	57.7% 15/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Gastroesophageal reflux disease	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Mucositis oral	50.0% 13/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Nausea	53.8% 14/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Oral pain	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Rectal hemorrhage	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Gastrointestinal disorders Vomiting	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Disease progression	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Edema face	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Edema limbs	26.9% 7/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Facial pain	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Fatigue	88.5% 23/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Fever	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Gait disturbance	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders General disorders and administration site conditions - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Localized edema	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Malaise	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Neck edema	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Non-cardiac chest pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
General disorders Pain	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Immune system disorders Autoimmune disorder	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Hepatic infection	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Lung infection	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Salivary gland infection	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Skin infection	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Thrush	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Tooth infection	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Infections and infestations Viremia	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Injury, poisoning and procedural complications Bruising	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Injury, poisoning and procedural complications Fall	15.4% 4/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Injury, poisoning and procedural complications Fracture	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Injury, poisoning and procedural complications Infusion related reaction	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Alanine aminotransferase increased	92.3% 24/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Alkaline phosphatase increased	57.7% 15/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Aspartate aminotransferase increased	88.5% 23/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Blood bilirubin increased	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Blood lactate dehydrogenase increased	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Creatinine increased	61.5% 16/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Electrocardiogram QT corrected interval prolonged	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations INR increased	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Lipase increased	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Neutrophil count decreased	23.1% 6/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Platelet count decreased	30.8% 8/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Serum amylase increased	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations Weight loss	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Investigations White blood cell decreased	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Anorexia	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Dehydration	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hypercalcemia	15.4% 4/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hyperglycemia	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hyperkalemia	23.1% 6/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hyperlipidemia	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hypoalbuminemia	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hypocalcemia	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hypokalemia	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hypomagnesemia	26.9% 7/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Metabolism and nutrition disorders Hyponatremia	84.6% 22/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 4/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Arthritis	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Back pain	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Bone pain	26.9% 7/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Flank pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Muscle cramp	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Neck pain	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Musculoskeletal and connective tissue disorders Trismus	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Cognitive disturbance	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Dizziness	15.4% 4/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Dysarthria	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Dysgeusia	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Extrapyramidal disorder	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Headache	19.2% 5/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Memory impairment	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Nervous system disorders - Other, specify	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Paresthesia	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Peripheral sensory neuropathy	30.8% 8/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Nervous system disorders Somnolence	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Psychiatric disorders Anxiety	23.1% 6/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Psychiatric disorders Depression	15.4% 4/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Psychiatric disorders Insomnia	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Psychiatric disorders Irritability	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Renal and urinary disorders Renal and urinary disorders - Other, specify	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Renal and urinary disorders Urinary incontinence	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Renal and urinary disorders Urinary tract obstruction	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Reproductive system and breast disorders Erectile dysfunction	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Reproductive system and breast disorders Pelvic pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Cough	26.9% 7/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Dyspnea	46.2% 12/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Productive cough	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Sore throat	15.4% 4/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Voice alteration	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Respiratory, thoracic and mediastinal disorders Wheezing	11.5% 3/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Alopecia	23.1% 6/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Dry skin	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Nail changes	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Pruritus	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Rash maculo-papular	92.3% 24/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Scalp pain	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Vascular disorders Hypertension	42.3% 11/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Vascular disorders Hypotension	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Vascular disorders Lymphedema	3.8% 1/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.
Vascular disorders Thromboembolic event	7.7% 2/26 • Median follow-up time for adverse events was 2.3 months (range 0.7-21.9 months). Median follow-up time for survival was 6.5 months (range 0.7 - 26 months). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose, results in death; is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event,suspected transmission of an infectious agent via the study drug is an SAE.

Additional Information

Glenn J. Hanna, M.D.

Dana-Farber Cancer Institute

Phone: 617-632-309

Email: glenn_hanna@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place