Trial Outcomes & Findings for A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies (NCT NCT02205333)
NCT ID: NCT02205333
Last Updated: 2017-06-28
Results Overview
The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
From the first dose of study treatment through 28 days after the first dose (up to 28 days)
Results posted on
2017-06-28
Participant Flow
A total of 58 participants were screened at 13 sites in the United States of America (USA).
A total of 58 participants were screened for this study, of which 48 participants were enrolled and received study treatment.
Participant milestones
| Measure |
MEDI6469 6 Milligram/Kilogram (mg/kg)
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
3
|
7
|
6
|
7
|
7
|
3
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
1
|
0
|
1
|
4
|
2
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
2
|
7
|
5
|
3
|
5
|
2
|
0
|
Reasons for withdrawal
| Measure |
MEDI6469 6 Milligram/Kilogram (mg/kg)
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
6
|
2
|
6
|
5
|
3
|
3
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Baseline characteristics by cohort
| Measure |
MEDI6469 6 Milligram/Kilogram (mg/kg)
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
63.8 Years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
48.0 Years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
61.3 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
57.5 Years
STANDARD_DEVIATION 19.4 • n=31 Participants
|
66.6 Years
STANDARD_DEVIATION 14.5 • n=30 Participants
|
62.6 Years
STANDARD_DEVIATION 9.1 • n=3 Participants
|
70.3 Years
STANDARD_DEVIATION 4.6 • n=6 Participants
|
73.0 Years
STANDARD_DEVIATION NA • n=114 Participants
|
61.9 Years
STANDARD_DEVIATION 12.2
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study treatment through 28 days after the first dose (up to 28 days)Population: DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.
The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of MEDI6469
|
NA milligram per kilogram (mg/kg)
Dose escalation was completed without determination of MTD.
|
NA milligram per kilogram (mg/kg)
Dose escalation was completed without determination of MTD.
|
NA milligram per kilogram (mg/kg)
Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.
|
NA milligram per kilogram (mg/kg)
Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.
|
NA milligram per kilogram (mg/kg)
Dose escalation was completed without determination of MTD.
|
NA milligram per kilogram (mg/kg)
Dose escalation was completed without determination of MTD.
|
NA milligram per kilogram (mg/kg)
Dose escalation was completed without determination of MTD.
|
NA milligram per kilogram (mg/kg)
Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.
|
NA milligram per kilogram (mg/kg)
Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.
|
PRIMARY outcome
Timeframe: From the first dose of study treatment through 28 days after the first dose (up to 28 days)Population: DLT-evaluable population
The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal \[ULN\] or total bilirubin higher than 5×ULN; any \>=Grade 2 pneumonitis that did not resolve to \<=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (\<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to \<=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (\>=) Grade 3 lymphopenia (unless clinically significant).
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With DLTs
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)Population: As-treated population: all the participants who received any study treatment.
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
8 Participant
|
6 Participant
|
3 Participant
|
7 Participant
|
6 Participant
|
7 Participant
|
7 Participant
|
3 Participant
|
1 Participant
|
PRIMARY outcome
Timeframe: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)Population: As-treated population
A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events
|
4 Participant
|
3 Participant
|
1 Participant
|
5 Participant
|
3 Participant
|
3 Participant
|
3 Participant
|
2 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)Population: As-treated population
Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell \[WBC\] count with differential, red blood cell \[RBC\] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume \[MCV\], and mean corpuscular hemoglobin concentration \[MCHC\]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen \[BUN\], bicarbonate, glucose, aspartate transaminase \[AST\], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase \[GGT\], lactate dehydrogenase, uric acid, potassium, alanine transaminase \[ALT\], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Anemia
|
2 Participant
|
2 Participant
|
2 Participant
|
2 Participant
|
2 Participant
|
1 Participant
|
3 Participant
|
1 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood creatinine increased
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
2 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Neutropenia
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Aspartate aminotransferase increased
|
1 Participant
|
0 Participant
|
0 Participant
|
3 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood glucose increased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood thyroid stimulating hormone increased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Iron deficiency
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Neutrophil count increased
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Neutrophil count decreased
|
0 Participant
|
0 Participant
|
2 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Lymphopenia
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood iron decreased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hemoglobin decreased
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Lymphocyte count decreased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Platelet count decreased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Thrombocytopenia
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypernatremia
|
1 Participant
|
1 Participant
|
1 Participant
|
3 Participant
|
2 Participant
|
0 Participant
|
2 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypokalemia
|
1 Participant
|
1 Participant
|
1 Participant
|
2 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypomagnesemia
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
2 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood alkaline phosphatase increased
|
0 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
2 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hyperglycemia
|
2 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Alanine aminotransferase increased
|
1 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Gamma-glutamyltransferase increased
|
1 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
2 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypercalcemia
|
2 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hyperkalemia
|
0 Participant
|
0 Participant
|
2 Participant
|
0 Participant
|
2 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypoalbuminemia
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
2 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hyperuricemia
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood bilirubin increased
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypophosphatemia
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood cholesterol increased
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypocalcemia
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypothyroidism
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Liver function test increased
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Tri-iodothyronine free decreased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Troponin increased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Thyroxine free decreased
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hematuria
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Activated partial thromboplastin time prolonged
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)Population: As-treated population
Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Hypertension
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Bradycardia
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Pyrexia
|
1 Participant
|
2 Participant
|
2 Participant
|
2 Participant
|
0 Participant
|
3 Participant
|
2 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Dyspnea
|
0 Participant
|
2 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
2 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Hypotension
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Sinus tachycardia
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Dyspnea exertional
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Tachycardia
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Hypoxia
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Wheezing
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)Population: As-treated population
Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
SECONDARY outcome
Timeframe: From study entry until early termination (up to 1 year)Population: As-treated population
Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
PR
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Best Overall Response (BOR)
CR
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Best Overall Response (BOR)
SD
|
12.5 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
28.6 Percentage of participants
|
33.3 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
100.0 Percentage of participants
|
|
Best Overall Response (BOR)
PD
|
50.0 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
42.9 Percentage of participants
|
50.0 Percentage of participants
|
42.9 Percentage of participants
|
100.0 Percentage of participants
|
66.7 Percentage of participants
|
0 Percentage of participants
|
|
Best Overall Response (BOR)
NE
|
37.5 Percentage of participants
|
66.7 Percentage of participants
|
0 Percentage of participants
|
28.6 Percentage of participants
|
0 Percentage of participants
|
42.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From study entry until early termination (up to 1 year)Population: As-treated population
Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment \>= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From study entry until early termination (up to 1 year)Population: As-treated population
Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for \>= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate
|
12.5 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
28.6 Percentage of participants
|
50.0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Study entry until early termination (up to 1 year)Population: All the participants with an OR were included.
Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=1 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
—
|
—
|
—
|
368 Days
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Study entry until early termination (up to 1 year)Population: As-treated population
Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.8 Months
Interval 0.9 to 3.5
|
1.8 Months
Interval 1.8 to 1.8
|
1.9 Months
Interval 1.8 to 6.4
|
2.8 Months
Interval 0.7 to 6.7
|
5.6 Months
Interval 1.0 to 17.8
|
1.8 Months
Interval 1.0 to 6.4
|
1.4 Months
Interval 1.0 to 1.8
|
1.0 Months
Interval 0.9 to
Not evaluable due to insufficient number of participants achieved this endpoint
|
5.4 Months
Not evaluable due to insufficient number of participants achieved this endpoint
|
SECONDARY outcome
Timeframe: From Study entry until early termination (up to 1 year)Population: As-treated population
The OS was the duration from the start of study treatment until death due to any cause.
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
6.1 Months
Interval 0.9 to
Not evaluable due to insufficient number of participants achieved this endpoint
|
6.5 Months
Interval 1.8 to 10.7
|
13.1 Months
Interval 11.2 to
Not evaluable due to insufficient number of participants achieved this endpoint
|
6.7 Months
Interval 2.0 to 12.5
|
11.2 Months
Interval 1.2 to 17.8
|
NA Months
Interval 1.0 to
Not evaluable due to insufficient number of participants achieved this endpoint
|
2.9 Months
Interval 2.5 to
Not evaluable due to insufficient number of participants achieved this endpoint
|
3.3 Months
Interval 1.7 to
Not evaluable due to insufficient number of participants achieved this endpoint
|
NA Months
Not evaluable due to insufficient number of participants achieved this endpoint
|
SECONDARY outcome
Timeframe: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatmentPopulation: All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
133.76 microgram per milliliter
Standard Deviation 34.87
|
188.87 microgram per milliliter
Standard Deviation 59.88
|
49.00 microgram per milliliter
Standard Deviation 1.29
|
43.67 microgram per milliliter
Standard Deviation 7.99
|
40.21 microgram per milliliter
Standard Deviation 8.20
|
42.10 microgram per milliliter
Standard Deviation 6.63
|
234.91 microgram per milliliter
Standard Deviation 56.05
|
31.68 microgram per milliliter
Standard Deviation 5.06
|
289.40 microgram per milliliter
Standard Deviation NA
Not evaluable due to insufficient number of participants achieved this endpoint
|
SECONDARY outcome
Timeframe: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.Population: All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
|
556.92 day*microgram per milliliter
Standard Deviation 166.95
|
873.16 day*microgram per milliliter
Standard Deviation 328.74
|
169.34 day*microgram per milliliter
Standard Deviation 18.15
|
183.09 day*microgram per milliliter
Standard Deviation 26.27
|
144.91 day*microgram per milliliter
Standard Deviation 33.07
|
169.65 day*microgram per milliliter
Standard Deviation 45.98
|
998.25 day*microgram per milliliter
Standard Deviation 400.12
|
145.55 day*microgram per milliliter
Standard Deviation 16.86
|
1619.73 day*microgram per milliliter
Standard Deviation NA
Not evaluable due to insufficient number of participants achieved this endpoint
|
SECONDARY outcome
Timeframe: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.Population: All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Systemic Clearance (CL)
|
0.81 liter per day
Standard Deviation 0.224
|
0.84 liter per day
Standard Deviation 0.246
|
1.02 liter per day
Standard Deviation 0.155
|
0.89 liter per day
Standard Deviation 0.132
|
1.04 liter per day
Standard Deviation 0.288
|
1.0 liter per day
Standard Deviation 0.266
|
0.84 liter per day
Standard Deviation 0.173
|
1.11 liter per day
Standard Deviation 0.188
|
0.77 liter per day
Standard Deviation NA
Not evaluable due to insufficient number of participants achieved this endpoint
|
SECONDARY outcome
Timeframe: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.Population: All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half-Life (T1/2)
|
2.83 Day
Standard Deviation 0.83
|
3.20 Day
Standard Deviation 1.23
|
1.56 Day
Standard Deviation 0.04
|
2.86 Day
Standard Deviation 0.68
|
2.73 Day
Standard Deviation 0.65
|
3.30 Day
Standard Deviation 0.68
|
2.98 Day
Standard Deviation 1.06
|
3.75 Day
Standard Deviation 1.03
|
4.19 Day
Standard Deviation NA
Not evaluable due to insufficient number of participants achieved this endpoint
|
SECONDARY outcome
Timeframe: All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)Population: All the participants who received at least a one dose of MEDI6469.
The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).
Outcome measures
| Measure |
MEDI6469 6 mg/kg
n=8 Participants
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 Participants
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
n=3 Participants
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
n=1 Participants
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)
|
5 Participant
|
4 Participant
|
3 Participant
|
6 Participant
|
5 Participant
|
6 Participant
|
4 Participant
|
1 Participant
|
0 Participant
|
Adverse Events
MEDI6469 6 Milligram/Kilogram (mg/kg)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI6469 10 mg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI6469 6 Milligram/Kilogram (mg/kg)
n=8 participants at risk
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 participants at risk
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 participants at risk
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
n=3 participants at risk
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
n=1 participants at risk
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Ascites
|
25.0%
2/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Asthenia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Infection
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Lung infection
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Pleural infection
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Pneumonia
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Wound infection
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
Other adverse events
| Measure |
MEDI6469 6 Milligram/Kilogram (mg/kg)
n=8 participants at risk
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
|
MEDI6469 10 mg/kg
n=6 participants at risk
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
|
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
n=3 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
|
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
n=7 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
|
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
n=6 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
|
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
n=7 participants at risk
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
n=7 participants at risk
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
|
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
n=3 participants at risk
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
n=1 participants at risk
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
50.0%
3/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
66.7%
2/3 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
50.0%
3/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
57.1%
4/7 • Number of events 9 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
57.1%
4/7 • Number of events 5 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
50.0%
3/6 • Number of events 5 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Asthenia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 5 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
3/3 • Number of events 5 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
57.1%
4/7 • Number of events 6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
66.7%
4/6 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Influenza like illness
|
25.0%
2/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
66.7%
2/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
50.0%
3/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
25.0%
2/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 4 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
66.7%
2/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
42.9%
3/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 5 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
50.0%
3/6 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 5 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
100.0%
1/1 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
1/3 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
14.3%
1/7 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/6 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
28.6%
2/7 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
2/8 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
16.7%
1/6 • Number of events 1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
33.3%
2/6 • Number of events 2 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/7 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/3 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
0.00%
0/1 • From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER