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Trial Outcomes & Findings for A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (NCT NCT03311334)

NCT ID: NCT03311334

Last Updated: 2024-04-18

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

From the date of signing informed consent until 30 days after last dose for an average of 3 months.

Results posted on

2024-04-18

Participant Flow

Participants who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.

Participant milestones

Participant milestones
Measure
Phase 1b - DSP-7888 10.5 mg + Nivolumab 240 mg
DSP-7888 Dosing Emulsion 10.5mg administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab 240mg IV.
Phase 1b - DSP-7888 10.5 mg + Pembrolizumab 200 mg/8mL
DSP-7888 Dosing Emulsion 10.5mg administered intradermally (ID) every 7 days until cycle 3, and then every 21 days for combination with Pembrolizumab 200mg/8mL IV starting on cycle 1 day 22 every 3 weeks.
Phase 2 - DSP-7888 10.5mg + Pembrolizumab 200mg/8mL
DSP-7888 Dosing Emulsion 10.5mg administered intradermally (ID) every 7 days until cycle 3, and then every 21 days for combination with Pembrolizumab 200mg/8mL IV starting on cycle 1 day 22 every 3 weeks.
Overall Study
STARTED
7
9
31
Overall Study
COMPLETED
7
9
31
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase 1b - Arm 1
n=7 Participants
DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
Phase 1b - Arm 2
n=9 Participants
DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Phase 2 - Ombipepimut-S + Pembrolizumab
n=31 Participants
The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study.
Total
n=47 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=99 Participants
5 Participants
n=107 Participants
13 Participants
n=206 Participants
22 Participants
n=7 Participants
Age, Categorical
>=65 years
3 Participants
n=99 Participants
4 Participants
n=107 Participants
18 Participants
n=206 Participants
25 Participants
n=7 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
4 Participants
n=107 Participants
31 Participants
n=206 Participants
37 Participants
n=7 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
5 Participants
n=107 Participants
0 Participants
n=206 Participants
10 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
2 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
White
7 Participants
n=99 Participants
8 Participants
n=107 Participants
27 Participants
n=206 Participants
42 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Region of Enrollment
United States
7 participants
n=99 Participants
9 participants
n=107 Participants
31 participants
n=206 Participants
47 participants
n=7 Participants

PRIMARY outcome

Timeframe: From the date of signing informed consent until 30 days after last dose for an average of 3 months.

Outcome measures

Outcome measures
Measure
Phase 1b - Arm 1
n=7 Participants
DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
Phase 1b - Arm 2
n=9 Participants
DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Phase 2 - Ombipepimut-S + Pembrolizumab
n=31 Participants
The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study.
Number of Patients With Adverse Events and Serious Adverse Events
7 Participants
9 Participants
31 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Only data from arm 2 of phase 1b were analyzed to determine the RP2D.

The RP2D was based on the data collected during phase 1b.

Outcome measures

Outcome measures
Measure
Phase 1b - Arm 1
n=9 Participants
DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
Phase 1b - Arm 2
DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Phase 2 - Ombipepimut-S + Pembrolizumab
The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study.
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs).
10.5 mg
—
—

PRIMARY outcome

Timeframe: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months

Population: Sponsor's decision to terminate the study, hence data for determination of ORR were not collected.

Defined as the proportion of patients who have achieved confirmed Complete Response or Partial Response by RECIST v1.1 based on investigator assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion

Population: Sponsor's decision to terminate study. No data were collected and analyzed.

Defined as the proportion of patients who have achieved confirmed complete response (CR) or partial response (PR) evaluated using RECIST v1.1 and iRECIST.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion

Population: Sponsor's decision to terminate study. No data were collected and analyzed.

Defined as the percentage of patients who have achieved best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 and iRECIST.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At week 4 for patients on the nivolumab arm and week 6 for patients on the pembrolizumab arm. Thereafter weeks 12, 18 and 24 and every 12 weeks until progression or death.

Population: Sponsor's decision to terminate study. Therefore no data were collected nor analyzed.

DOR is defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1 and iRECIST or death by any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months

Population: Sponsor's decision to terminate study. No data were collected and analyzed.

The percentage of participants with a complete response or partial response who have measurable disease at baseline imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Sponsor's decision to terminate study. No data were collected or analyzed.

Defined as the proportion of patients who neither progressed by RECIST (v.1.1) nor died before 6 months (24 weeks) from the first study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure
Phase 1b - Arm 1
n=7 Participants
DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
Phase 1b - Arm 2
n=9 Participants
DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Phase 2 - Ombipepimut-S + Pembrolizumab
The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study.
Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab
0 percentage of participants
0 percentage of participants
—

SECONDARY outcome

Timeframe: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression up to 24 months.

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the time from the first documentation of a response (CR or PR) until time of first documentation of disease progression by RECIST v1.1 or death by any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months.

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the percentage of patients who have achieved best overall response (BOR) of complete response, partial response, or stable disease per RECIST (v.1.1)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST v.1.1, or death by any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST (v.1.1), or death by any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 months from last dose of study treatment up to 24 months.

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the time from the date of first dose of study treatment to the date of death by any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the percentage of patients who have achieved confirmed immune complete response (iCR) or immune partial response (iPR), evaluated using iRECIST based on investigator's assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the percentage of patients who have achieved best overall response of iCR, iPR, or immune stable disease (iSD), per iRECIST

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by iRECIST or death by any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Defined as the time from the first documentation of response (iCR or iPR) until time of first documentation of disease progression by iRECIST, or death by any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.

Demonstrated by the number of participants with adverse events and serious adverse events

Outcome measures

Outcome data not reported

Adverse Events

Phase 1b - Arm 1

Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths

Phase 1b - Arm 2

Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths

Phase 2 - Ombipepimut-S + Pembrolizumab

Serious events: 8 serious events
Other events: 31 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Phase 1b - Arm 1
n=7 participants at risk
DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
Phase 1b - Arm 2
n=9 participants at risk
DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Phase 2 - Ombipepimut-S + Pembrolizumab
n=31 participants at risk
The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study.
Immune system disorders
Hypersensitivity
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Pyrexia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Syncope
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Spinal Cord Compression
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Diabetic Ketoacidosis
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hypoglycemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Urine Output Decreased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Blood and lymphatic system disorders
Haemorrhagic Anaemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Renal and urinary disorders
Acute Kidney Injury
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Renal and urinary disorders
Hydronephrosis
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Pnemonia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Fall
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Lower Limb Fracture
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Vascular disorders
Hypotension
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Cardiac disorders
Pericardial Effusion
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Cardiac disorders
Acute Myocardial Infarction
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Cardiac disorders
Cardiac Tamponade
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Abdominal Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Large Intestinal Obstruction
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Small Intestinal Obstruction
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
16.1%
5/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Abdominal Distension
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Ileus
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Nausea
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Vomiting
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.

Other adverse events

Other adverse events
Measure
Phase 1b - Arm 1
n=7 participants at risk
DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
Phase 1b - Arm 2
n=9 participants at risk
DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm. Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Phase 2 - Ombipepimut-S + Pembrolizumab
n=31 participants at risk
The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study.
Gastrointestinal disorders
Rectal Haemorrhage
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Stomatitis
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Oral Pain
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Injection Site Reaction
100.0%
7/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
100.0%
9/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
74.2%
23/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Decreased Appetite
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
55.6%
5/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
12.9%
4/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Fatigue
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
44.4%
4/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
48.4%
15/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Constipation
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
33.3%
3/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.6%
7/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Nausea
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
41.9%
13/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Pyrexia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
33.3%
3/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Dyspepsia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Vomiting
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
25.8%
8/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Dental Caries
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Diabetic Ketoacidosis
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Dysphagia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Localised Oedema
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Haematochezia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Melaena
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Diarrhoea
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.6%
7/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Ascites
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
16.1%
5/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Small Intestinal Obstruction
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
16.1%
5/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Flatulence
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Ileus
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Large Intestinal Obstruction
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Gastrointestinal disorders
Early Satiety
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Pain in Extremity
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Dysphonia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Hypophosphataemia
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Abdominal Pain Upper
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Chest Discomfort
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Infusion Related Reaction
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Night Sweats
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Non-cardiac Chest Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Periorbital Oedema
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Peripheral Swelling
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Sunburn
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Tooth Infection
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Abdominal Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
32.3%
10/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Abdominal Distension
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.6%
7/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Dry Mouth
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Injection Site Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Oedema peripheral
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
19.4%
6/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hypophosphataemia
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
General disorders
Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Headache
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
29.0%
9/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Insomnia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Dizziness
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Paraesthesia
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Presyncope
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Dysgeusia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Hot Flush
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Peripheral Sensory Neuropathy
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Syncope
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Nervous system disorders
Pyrexia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.6%
7/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Dehydration
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
16.1%
5/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hyperuricaemia
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Amylase Increased
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Blood Urine
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Fibrin D Dimer Increased
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
33.3%
3/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
19.4%
6/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hypokalaemia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
19.4%
6/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Blood Creatinine Increased
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Platelet Count Decreased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Vitamin B12 Deficiency
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Weight Increased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Renal and urinary disorders
Haematuria
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Lymphocyte Count Decreased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
9.7%
3/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Alanine Aminotransferase Increased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Aspartate Aminotransferase Increased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Blood Alkaline Phosphatase Increased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Gamma-glutamyltransferase Increased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Investigations
Weight Decreased
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
12.9%
4/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Blood and lymphatic system disorders
Anaemia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.6%
7/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Blood and lymphatic system disorders
Conjunctival Haemorrhage
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Blood and lymphatic system disorders
Thrombocytosis
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Cardiac disorders
Chest Pain
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Cardiac disorders
Electrocardiogram QT Prolonged
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Back Pain
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
12.9%
4/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Abdominal Pain
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
33.3%
3/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Arthralgia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
16.1%
5/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
12.9%
4/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Myalgia
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Osteomyelitis
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Osteonecrosis
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Muscle Spasms
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
12.9%
4/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Flank Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Musculoskeletal and connective tissue disorders
Bone Pain
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Pneumonia
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Influenza Like Illness
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
16.1%
5/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Sinusitis
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Herpes Zoster
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Nail Disorder
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Nail Infection
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Otitis Media
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Urinary Tract Infection
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
12.9%
4/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Corona Virus Infection
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Oral Infection
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Infections and infestations
Myringitis
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Psychiatric disorders
Depression
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Psychiatric disorders
Confusional State
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Psychiatric disorders
Agitation
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Psychiatric disorders
Anxiety
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Psychiatric disorders
Psychomotor Hyperactivity
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Vascular disorders
Hypotension
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Fall
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
22.2%
2/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Arthropod Bite
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Contusion
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Fibula Fracture
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Fracture
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Laceration
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Spinal Compression Fracture
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Spinal Cord Compression
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Lower Limb Fracture
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Tibia Fracture
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Endocrine disorders
Hypothyroidism
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
6.5%
2/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Injury, poisoning and procedural complications
Hypersensitivity
28.6%
2/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Ear and labyrinth disorders
Tympanic Membrane Perforation
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Ear and labyrinth disorders
Tinnitus
14.3%
1/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Eye disorders
Vision Blurred
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
3.2%
1/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Eye disorders
Dry Eye
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Eye disorders
Eye Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Eye disorders
Photopsia
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
0.00%
0/7 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
11.1%
1/9 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.
0.00%
0/31 • Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 12 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 24 months.

Additional Information

Mimi M. Lee, MSW, CCRP

Sumitomo Pharma America

Phone: 617-674-6800

Results disclosure agreements

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

Restriction type: GT60