Trial Outcomes & Findings for Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma (NCT NCT05373901)
NCT ID: NCT05373901
Last Updated: 2024-10-04
Results Overview
Number of participants with treatment-emergent adverse events (TEAEs) and serious treatment-emergent adverse event, characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, relationship to study treatment, and other safety assessments.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
Results posted on
2024-10-04
Participant Flow
Participants were enrolled in three study centers across China. The study was conducted from June 7th, 2022, and completed on June 29, 2023.
Participant milestones
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days.
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Age, Continuous
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5.0 years
STANDARD_DEVIATION 1.41 • n=8 Participants
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Sex: Female, Male
Female
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2 Participants
n=8 Participants
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Sex: Female, Male
Male
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6 Participants
n=8 Participants
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PRIMARY outcome
Timeframe: From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 monthPopulation: The Safety Analysis Set included all participants who received at least one dose of dinutuximab beta.
Number of participants with treatment-emergent adverse events (TEAEs) and serious treatment-emergent adverse event, characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, relationship to study treatment, and other safety assessments.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Number of Participants With Adverse Events (AEs)
Participants With At Least 1 TEAE
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8 Participants
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Number of Participants With Adverse Events (AEs)
Participants with Serious TEAEs
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1 Participants
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab Beta
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3956.3 hours*micrograms/milliliter (h*ug/mL)
Geometric Coefficient of Variation 33.11
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab Beta
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4228.6 h*ug/mL
Geometric Coefficient of Variation 31.94
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Maximum Observed Serum Concentration (Cmax) of Dinutuximab Beta
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13.49 ug/mL
Geometric Coefficient of Variation 32.682
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Time to Maximum Serum Concentration (Tmax) of Dinutuximab Beta
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240.4 hours
Interval 168.0 to 252.0
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Half-Life (t1/2) of Dinutuximab Beta
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253.9 hours
Interval 200.0 to 332.0
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Clearance (CL) of Dinutuximab Beta
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17.19 mL/h
Geometric Coefficient of Variation 34.627
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Volume of Distribution During Terminal Phase (Vz) of Dinutuximab Beta
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6295.9 mL
Geometric Coefficient of Variation 48.87
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PRIMARY outcome
Timeframe: From Cycle 1 Day 1 pre-dose to Cycle 2 Day 1 pre-dose (Each cycle is 35 Days)Population: Pharmacokinetic (PK) Analysis Set was defined as participants who had at least 1 available postbaseline PK data in the Safety Analysis Set.
Outcome measures
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 Participants
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab Beta: Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2/day) for 10 consecutive days
13-cis-Retinoic Acid: 13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Volume of Distribution at Steady State (Vss) of Dinutuximab Beta
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3594.0 mL
Geometric Coefficient of Variation 37.12
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Adverse Events
Dinutuximab Beta + 13-cis-Retinoic Acid
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 participants at risk
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab beta was administered intravenously at a dosage of 10 mg/m2/day for 10 days
13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m², divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Infections and infestations
Pneumonia
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12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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Metabolism and nutrition disorders
Decreased appetite
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12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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Other adverse events
| Measure |
Dinutuximab Beta + 13-cis-Retinoic Acid
n=8 participants at risk
The study recruited participants who were hospitalized (with full resuscitation equipment) on Day 1 of each cycle and received continuous infusion of dinutuximab beta for 10 consecutive days in 35-day cycles. Participants could be discharged from the hospital at the investigator's discretion. Participants continued to receive 13-cis-retinoic acid orally for 14 days after completion of dinutuximab beta infusion (day 12-25 in each cycle).
Dinutuximab beta was administered intravenously at a dosage of 10 mg/m2/day for 10 days
13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m², divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.
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Blood and lymphatic system disorders
Anaemia
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62.5%
5/8 • Number of events 21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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Blood and lymphatic system disorders
Eosinophilia
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25.0%
2/8 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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Blood and lymphatic system disorders
Leukocytosis
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25.0%
2/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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|
Blood and lymphatic system disorders
Neutropenia
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12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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|
Blood and lymphatic system disorders
Thrombocytopenia
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25.0%
2/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
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|
Cardiac disorders
Sinus tachycardia
|
37.5%
3/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Supraventricular tachycardia
|
25.0%
2/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Conjunctivitis allergic
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Dry eye
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Photophobia
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Swelling of eyelid
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Vision blurred
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
8/8 • Number of events 17 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Anal pruritus
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Angular cheilitis
|
50.0%
4/8 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
6/8 • Number of events 18 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Chills
|
50.0%
4/8 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Face oedema
|
25.0%
2/8 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Gait disturbance
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
100.0%
8/8 • Number of events 42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19
|
50.0%
4/8 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Catheter site infection
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Gastrointestinal infection
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Myringitis
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
4/8 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Alanine aminotransferase increased
|
75.0%
6/8 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Alpha tumour necrosis factor increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Aspartate aminotransferase increased
|
62.5%
5/8 • Number of events 13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood cholesterol increased
|
12.5%
1/8 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatinine increased
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood fibrinogen decreased
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood lactate dehydrogenase increased
|
50.0%
4/8 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Brain natriuretic peptide increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
C-reactive protein increased
|
50.0%
4/8 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Electrocardiogram QT prolonged
|
25.0%
2/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Fibrin D dimer increased
|
37.5%
3/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Gamma-glutamyltransferase increased
|
62.5%
5/8 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Heart rate increased
|
50.0%
4/8 • Number of events 55 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Interleukin level increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Interleukin-2 receptor increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil count decreased
|
50.0%
4/8 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil percentage increased
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Oxygen saturation decreased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
50.0%
4/8 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Procalcitonin increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
SARS-CoV-2 test positive
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Weight increased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
6/8 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
12.5%
1/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
50.0%
4/8 • Number of events 13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
2/8 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
4/8 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
37.5%
3/8 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypophagia
|
37.5%
3/8 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
37.5%
3/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Occipital neuralgia
|
12.5%
1/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Reproductive system and breast disorders
Pruritus genital
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
62.5%
5/8 • Number of events 13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Macule
|
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Papule
|
37.5%
3/8 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
75.0%
6/8 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
37.5%
3/8 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Capillary leak syndrome
|
25.0%
2/8 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Haemorrhage
|
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypotension
|
62.5%
5/8 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 40 days after the last dose; up to approximately 1 year and 1 month
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 40 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights
- Publication restrictions are in place
Restriction type: OTHER