Trial · NCT01137071
Registered outcomes58
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 58
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy | 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first. | PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented. |
| Secondary | 1-year Disease Progression-free Survival Rate | 1 year from the beginning of platinum-based rescue chemotherapy start date | |
| Secondary | Two-year Overall Survival Rate | 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy. | Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause. |
| Secondary | Safety - Vital Signs - Heart Rate | Baseline, week 2 , week 4 and week 27 | Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks. |
| Secondary | Safety - Vital Signs - Respiratory Rate | Baseline, week 2, week 4 and week 27 | Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks. |
| Secondary | Safety - Vital Signs - Systolic and Diastolic Blood Pressure | Baseline, week 2, week 4 and week 27 | Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks. |
| Secondary | Safety - Vital Signs - Temperature | Baseline, week 2, week 4 and week 27 | Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks. |
| Secondary | Incidence of Adverse Events (AEs) - Gastrointestinal Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Immune System Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Nervous System Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Investigations | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia) | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety) | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Vascular Disorders | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
| Secondary | Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain) | From the first infusion of medication to 30 days after the last one | The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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