Trial Outcomes & Findings for Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL (NCT NCT05296525)
NCT ID: NCT05296525
Last Updated: 2025-03-25
Results Overview
DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. acute graft-versus-host disease (aGvHD) will be assessed according to the Consensus Conference on aGvHD grading: Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extend
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Day 28
Results posted on
2025-03-25
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Phase I) -Dose Level 1
Phase I dose escalation with up to 4 dose levels to reach maximum tolerated dose (MTD) and determine recommended Phase II dose (RP2D).
Dose Level 1: GDA-201 2.5x10\^7 cells/kg given in one administration (Day 0)
Patients followed up to 1y, or death or disease progression, whichever comes first
|
Cohort 1 (Phase I) - Dose Level 2
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^7 cells/kg given in one (Day 0) or 2 (Day 0 and Day 2) administration(s) Patients followed up to 1y, or death or disease progression, whichever comes first
|
Cohort 1 (Phase I) - Dose Level 3
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 3: GDA-201 1x10\^8 cells/kg given in two administrations (Day 0 and Day 2) Patients followed up to 1y, or death or disease progression, whichever comes first
|
Cohort 1 (Phase I) - Dose Level 4
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 4: GDA-201 2x10\^8 cells/kg given in two administrations (Day 0 and Day 2) Patients followed up to 1y, or death or disease progression, whichever comes first
|
|---|---|---|---|---|
|
Dose Level 1 (Week 1 to Week 52)
STARTED
|
4
|
0
|
0
|
0
|
|
Dose Level 1 (Week 1 to Week 52)
COMPLETED
|
4
|
0
|
0
|
0
|
|
Dose Level 1 (Week 1 to Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 2 (Week 23 - Week 75)
STARTED
|
0
|
3
|
0
|
0
|
|
Dose Level 2 (Week 23 - Week 75)
COMPLETED
|
0
|
3
|
0
|
0
|
|
Dose Level 2 (Week 23 - Week 75)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 3 (Week 40 - Week 92)
STARTED
|
0
|
0
|
3
|
0
|
|
Dose Level 3 (Week 40 - Week 92)
COMPLETED
|
0
|
0
|
3
|
0
|
|
Dose Level 3 (Week 40 - Week 92)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 4 (Week 62 - Week 114)
STARTED
|
0
|
0
|
0
|
3
|
|
Dose Level 4 (Week 62 - Week 114)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 4 (Week 62 - Week 114)
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 (Phase I) -Dose Level 1
Phase I dose escalation with up to 4 dose levels to reach maximum tolerated dose (MTD) and determine recommended Phase II dose (RP2D).
Dose Level 1: GDA-201 2.5x10\^7 cells/kg given in one administration (Day 0)
Patients followed up to 1y, or death or disease progression, whichever comes first
|
Cohort 1 (Phase I) - Dose Level 2
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^7 cells/kg given in one (Day 0) or 2 (Day 0 and Day 2) administration(s) Patients followed up to 1y, or death or disease progression, whichever comes first
|
Cohort 1 (Phase I) - Dose Level 3
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 3: GDA-201 1x10\^8 cells/kg given in two administrations (Day 0 and Day 2) Patients followed up to 1y, or death or disease progression, whichever comes first
|
Cohort 1 (Phase I) - Dose Level 4
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 4: GDA-201 2x10\^8 cells/kg given in two administrations (Day 0 and Day 2) Patients followed up to 1y, or death or disease progression, whichever comes first
|
|---|---|---|---|---|
|
Dose Level 4 (Week 62 - Week 114)
Early termination by Sponsor
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL
Baseline characteristics by cohort
| Measure |
GDA-201 - Cohort 1 (Phase I) - Dose Level 1
n=4 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 1: GDA-201 2.5x10\^7 cells/kg
|
GDA-201 - Cohort 1 (Phase I) - Dose Level 2
n=3 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^7 cells/kg
|
GDA-201 - Cohort 1 (Phase I) - Dose Level 3
n=3 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 3: GDA-201 2.5x10\^8 cells/kg
|
GDA-201 - Cohort 1 (Phase I) - Dose Level 4
n=3 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 4: GDA-201 5x10\^8 cells/kg
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Patient diagnosis
Follicular lymphoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Patient diagnosis
Diffuse large B-cell lymphoma
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Patient diagnosis
High grade B-cell lymphoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Patient diagnosis
Marginal zone lymphoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Patient diagnosis
Mantle cell lymphoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 28DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. acute graft-versus-host disease (aGvHD) will be assessed according to the Consensus Conference on aGvHD grading: Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extend
Outcome measures
| Measure |
GDA-201 - Cohort 1 (Phase I) - Dose Level 1
n=4 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 1: GDA-201 2.5x10\^7 cells/kg
|
GDA-201 - Cohort 1 (Phase I) - Dose Level 2
n=3 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^7 cells/kg
|
GDA-201 - Cohort 1 (Phase I) - Dose Level 3
n=3 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 3: GDA-201 1x10\^8 cells/kg
|
GDA-201 - Cohort 1 (Phase I) - Dose Level 4
n=3 Participants
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^8 cells/kg
|
|---|---|---|---|---|
|
Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs)
Patients who experienced dose limiting toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs)
Patients who did not experience DLT
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs)
Patients not evaluable for DLT
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Study was early terminated by Sponsor prior to initiation of the phase II
Patients will be assessed after the infusion of GDA-201 for level of response.
Outcome measures
Outcome data not reported
Adverse Events
GDA-201 Cohort 1 (Phase I) - Dose Level 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
GDA-201 Cohort 1 (Phase I) - Dose Level 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
GDA-201 Cohort 1 (Phase I) - Dose Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
GDA-201 Cohort 1 (Phase I) - Dose Level 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GDA-201 Cohort 1 (Phase I) - Dose Level 1
n=4 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 1: GDA-201 2.5x10\^7 cells/kg given in one administration (Day 0)
|
GDA-201 Cohort 1 (Phase I) - Dose Level 2
n=3 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^7 cells/kg given in one (Day 0) or two (Day 0 and +2) administrations
|
GDA-201 Cohort 1 (Phase I) - Dose Level 3
n=3 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 3: GDA-201 5x10\^7 cells/kg given in two administrations (Day 0 and +2)
|
GDA-201 Cohort 1 (Phase I) - Dose Level 4
n=3 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 4: GDA-201 5x10\^7 cells/kg given in two administrations (Day 0 and +2)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary obstruction
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Generalised edema
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Disease progression
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
Other adverse events
| Measure |
GDA-201 Cohort 1 (Phase I) - Dose Level 1
n=4 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 1: GDA-201 2.5x10\^7 cells/kg given in one administration (Day 0)
|
GDA-201 Cohort 1 (Phase I) - Dose Level 2
n=3 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 2: GDA-201 5x10\^7 cells/kg given in one (Day 0) or two (Day 0 and +2) administrations
|
GDA-201 Cohort 1 (Phase I) - Dose Level 3
n=3 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 3: GDA-201 5x10\^7 cells/kg given in two administrations (Day 0 and +2)
|
GDA-201 Cohort 1 (Phase I) - Dose Level 4
n=3 participants at risk
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D).
Dose Level 4: GDA-201 5x10\^7 cells/kg given in two administrations (Day 0 and +2)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Abdominal distention
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 6 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 7 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Reproductive system and breast disorders
Breast swelling
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Catheter site pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
chills
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Culture urine positive
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Disease progression
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Nervous system disorders
Head discomfort
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Injury, poisoning and procedural complications
Hepatobiliary procedural complication
|
25.0%
1/4 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • Number of events 4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Renal and urinary disorders
Incontinence
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Infusion site pain
|
25.0%
1/4 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Injection site pain
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 11 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 9 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
100.0%
3/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Nervous system disorders
Neuralgia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 6 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Number of events 4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Oedema peripheral
|
50.0%
2/4 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Pain
|
50.0%
2/4 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Proctalgia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Psychiatric disorders
Restlessness
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 5 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Infections and infestations
Tinea cruris
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
0.00%
0/3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
33.3%
1/3 • Number of events 3 • Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place