Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015825-36 | EudraCT Number |
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Study was terminated by sponsor due to futile results in NCT00849667 study.
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An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORAb-003 | Experimental | Maintenance infusions of MORAb-003 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORAb-003 | Drug | Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by GCIG | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | 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. |
Inclusion Criteria:
Exclusion Criteria:
• Subjects that discontinued the MORAb-003-002 study for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| Susan Weil, MD | Morphotek | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | Chula Vista | California | 91911 | United States | ||
| South Texas Oncology & Hematology |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
As per the planned analysis, the intention to treat population analysis set included all 3 participants who were enrolled and received at least 1 dose of farletuzumab in this extension-of-treatment study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Farletuzumab- All 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | 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. | 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. | Posted | Number | months | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Farletuzumab 62.5 mg/m^2 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
Study was terminated by sponsor due to futile results in the NCT00849667 (MORAb003-004) study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Medical Information | 888 422 4743 | esi_medinfo@eisai.com |
Not provided
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C527484 | farletuzumab |
Not provided
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| 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) |
| Overall Survival (OS) | 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. | 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) |
| Duration of Second Remission | 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. | 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) |
| Duration of Third Remission | 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. | 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) |
| From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months) |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Nationales Centrum fur Tumorerkrandungen | Heidelberg | 69120 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Farletuzumab 62.5 mg/m^2 | 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. |
| OG001 | Farletuzumab 100 mg/m^2 | 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. |
|
|
| Secondary | Progression-Free Survival (PFS) by GCIG | 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. | 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. | Posted | Number | months | 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) |
|
|
|
| Secondary | Overall Survival (OS) | 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. | 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. | Posted | Number | months | 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) |
|
|
|
| Secondary | Duration of Second Remission | 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. | 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. | Posted | Number | months | 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) |
|
|
|
| Secondary | Duration of Third Remission | 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. | 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. | Posted | Number | months | 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) |
|
|
|
| Other Pre-specified | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | 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. | Intent-to-treat population included all 3 participants who were enrolled. | Posted | Count of Participants | Participants | From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months) |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | 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. | 0 | 1 | 1 | 1 | 1 | 1 |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngeal abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
Not provided
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Participant 2 (dose group: 62.5 mg/m^2)-C: GCIG |
|
|
| Participant 3 (dose group: 100 mg/m^2): GCIG |
|
|
| Participant 2 (dose group: 62.5 mg/m^2)-C |
|
|
| Participant 3 (dose group: 100 mg/m^2) |
|
|
| Participant 2 (dose group: 62.5 mg/m^2)-C |
|
|
| Participant 3 (dose group: 100 mg/m^2) |
|
|