Trial Outcomes & Findings for An Open Label Extension Study of the Efficacy of MORAb-003 (NCT NCT01018563)
NCT ID: NCT01018563
Last Updated: 2021-12-08
Results Overview
The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (\>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter \[kU/L\]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)
Results posted on
2021-12-08
Participant Flow
Participants participated and received single-agent farletuzumab maintenance therapy in MORAb-003-002 study (NCT00318370), achieved normalization of cancer antigen 125 levels and/or tumor assessment of complete/partial response(or stable disease and an investigator's assessment of a clinical benefit) after receiving farletuzumab plus chemotherapy to enter study.
Study enrolled 3 participants who participated in the MORAb-003-002 study (NCT00318370), achieved a normalization of CA 125 levels and/or complete response or partial response after MORAb-003 in combination with standard chemotherapy, and received single-agent MORAb-003 maintenance therapy.
Participant milestones
| Measure |
Farletuzumab 62.5 mg/m^2
Participants received farletuzumab 62.5 milligram per meter square (mg/m\^2), intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Farletuzumab 62.5 mg/m^2
Participants received farletuzumab 62.5 milligram per meter square (mg/m\^2), intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
|
|---|---|---|
|
Overall Study
Termination of the study by Sponsor
|
2
|
1
|
Baseline Characteristics
An Open Label Extension Study of the Efficacy of MORAb-003
Baseline characteristics by cohort
| Measure |
Farletuzumab- All Participants
n=3 Participants
Participants received farletuzumab 62.5 or 100 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to 37.7 months in this study.
|
|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)Population: Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (\>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter \[kU/L\]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur.
Outcome measures
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 Participants
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 Participants
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
|---|---|---|
|
Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
Participant 1 (dose group: 62.5 mg/m^2)-C
|
77.2 months
|
—
|
|
Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
Participant 2 (dose group: 62.5 mg/m^2)-C
|
73.3 months
|
—
|
|
Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
Participant 3 (dose group: 100 mg/m^2)
|
—
|
18.0 months
|
SECONDARY outcome
Timeframe: From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)Population: Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
PFS was defined as the time from the date of first dose of study medication during the parent study MORAb-003-002 (NCT00318370) to the date of disease progression (either by GCIG for CA125 criteria or standard RECIST v.1.0 criteria) or to the date of death due to any cause in this study. PD per CA125 was defined as the first of 2 consecutive CA125 values \>2\*ULN (35 kU/L) on two occasions. Participants who were alive with no disease progression were censored at either the date of last CA125 assessment or date of last objective tumor evaluation, whichever was later. PFS was also censored if a participant received a non-study anticancer therapy or procedure, with censoring occurring at the date of the last RECIST or CA125 assessment prior to the start of a non-study anticancer therapy or procedure (whichever was earlier). C= data censored at earlier non-PD assessment if PD did not occur.
Outcome measures
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 Participants
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 Participants
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
|---|---|---|
|
Progression-Free Survival (PFS) by GCIG
Participant 2 (dose group: 62.5 mg/m^2)-C: GCIG
|
75.8 months
|
—
|
|
Progression-Free Survival (PFS) by GCIG
Participant 1 (dose group: 62.5 mg/m^2)-C: GCIG
|
77.8 months
|
—
|
|
Progression-Free Survival (PFS) by GCIG
Participant 3 (dose group: 100 mg/m^2): GCIG
|
—
|
25.1 months
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)Population: Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
OS was defined from the date of first dose of farletuzumab during the parent study MORAb-003-002 (NCT00318370) to date of death due to any cause. Participants who were alive had their OS time censored at the date they were last known to be alive. C= data censored at date participant was last known to be alive.
Outcome measures
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 Participants
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 Participants
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
|---|---|---|
|
Overall Survival (OS)
Participant 1 (dose group: 62.5 mg/m^2)-C
|
78.3 months
|
—
|
|
Overall Survival (OS)
Participant 2 (dose group: 62.5 mg/m^2)-C
|
76.7 months
|
—
|
|
Overall Survival (OS)
Participant 3 (dose group: 100 mg/m^2)
|
—
|
59.5 months
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)Population: Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
The prolongation of second and subsequent responses to chemotherapy plus farletuzumab relative to initial remission was assessed. Length of first remission was determined in the parent study MORAb-003-002 (NCT00318370). The length of second remission (i.e., the first remission in this study) was calculated using the following formula: '(carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1/30.4'. The length of second remission was censored at the date of study discontinuation if the participant did not receive any carboplatin/taxane therapy during this study. C = censored data.
Outcome measures
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 Participants
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 Participants
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
|---|---|---|
|
Duration of Second Remission
Participant 1 (dose group: 62.5 mg/m^2)
|
41.0 months
|
—
|
|
Duration of Second Remission
Participant 2 (dose group: 62.5 mg/m^2)-C
|
74.2 months
|
—
|
|
Duration of Second Remission
Participant 3 (dose group: 100 mg/m^2)
|
—
|
29.5 months
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months)Population: Intent-to-treat population included all 3 participants who were enrolled. Here "overall number of participants analyzed" are participants who were available for this outcome measure.
The length of third remission (i.e., second remission in this study) was calculated using the following formula: '(subsequent carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1)/30.4'. The length of third remission was censored at the date of study discontinuation if the participant did not receive subsequent chemotherapy (carboplatin/taxane) during this study. Censored data is reported for all participants.
Outcome measures
| Measure |
Farletuzumab 62.5 mg/m^2
n=1 Participants
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 Participants
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
|---|---|---|
|
Duration of Third Remission
|
37.3 months
|
25.0 months
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)Population: Intent-to-treat population included all 3 participants who were enrolled.
Best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Participants were assigned to one of the following categories of change in disease status: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as CR in both target and non-target lesions with no new lesions. PR was defined as CR in target lesions and incomplete response or SD in non-target lesions with no new lesions, or PR in target lesions and non-PD in non-target lesions with no new lesions. SD was defined as SD in target lesions and non-PD in non-target lesions with no new lesions. PD was defined as PD in target lesions, any non-target lesions with either absence or presence of new lesions, or any target lesions, PD in non-target lesions with either absence or presence of new lesions, or any target or non-target lesions with new lesions.
Outcome measures
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 Participants
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 Participants
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose which participants received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
|
|---|---|---|
|
Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria
CR
|
1 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria
SD
|
1 Participants
|
0 Participants
|
Adverse Events
Farletuzumab 62.5 mg/m^2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Farletuzumab 100 mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 participants at risk
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 participants at risk
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
General disorders
Disease progression
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
Other adverse events
| Measure |
Farletuzumab 62.5 mg/m^2
n=2 participants at risk
Participants received farletuzumab 62.5 mg/m\^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
|
Farletuzumab 100 mg/m^2
n=1 participants at risk
Participants received farletuzumab 100 mg/m\^2, intravenous infusion once weekly at the same dose participants received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 5 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Surgical and medical procedures
Tooth extraction
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 11 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
General disorders
Asthenia
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
General disorders
Local swelling
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
1/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Investigations
Haemoglobin decreased
|
50.0%
1/2 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Investigations
Red blood cell count decreased
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Investigations
White blood cell count decreased
|
50.0%
1/2 • Number of events 4 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 93 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 7 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Stomatitis
|
100.0%
2/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Colitis
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
1/2 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 3 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Pharyngeal abscess
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Infections and infestations
Tooth infection
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
0.00%
0/1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/2 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
100.0%
1/1 • Number of events 1 • For each participant, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
Intention to treat population analysis set included all 3 participants who were enrolled.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER