| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S033 | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin + Bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival at 6 Months (PFS-6) | Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). | Registration to 6 months |
| Time to Progressive Disease (PD) | Defined as the time from registration to PD, death or date of last contact. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date. | Registration to PD, death or date of last contact up to 66.56 months |
| Number of Participants With Adverse Events (AEs) or Deaths (Safety) | Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | Registration to study completion up to 67.56 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall response is confirmed complete response (CR) + partial response (PR). CR is complete disappearance of all measurable and evaluable disease, no new lesions, and no evidence of non-evaluable disease. PR is ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions (or the 2 largest lesions), no progression of evaluable disease and no new lesions. ORR is calculated as (total number of participants with CR or PR from the start of registration until disease progression) / (the total number of participants treated)*100. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bethesda | Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26643807 | Derived | Odia Y, Iwamoto FM, Moustakas A, Fraum TJ, Salgado CA, Li A, Kreisl TN, Sul J, Butman JA, Fine HA. A phase II trial of enzastaurin (LY317615) in combination with bevacizumab in adults with recurrent malignant gliomas. J Neurooncol. 2016 Mar;127(1):127-35. doi: 10.1007/s11060-015-2020-x. Epub 2015 Dec 7. | |
| 25098701 | Derived |
Not provided
Not provided
The reasons for discontinuation listed in the participant flow are the reasons the participants discontinued treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin + Bevacizumab (NEIAED) | Enzastaurin: 1125 milligrams (mg) loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on non-enzyme inducing antiepileptic drugs (NEIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of progressive disease (PD), significant toxicity, withdrawal of consent, or other discontinuation criteria were met. |
| FG001 | Enzastaurin + Bevacizumab (EIAED) | Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on enzyme inducing antiepileptic drugs (EIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin + Bevacizumab (NEIAED) | Enzastaurin: 1125 mg loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on NEIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met. |
| 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 | Progression-Free Survival at 6 Months (PFS-6) | Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). | All enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Registration to 6 months |
|
Not provided
Not provided
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 | Enzastaurin + Bevacizumab (NEIAED) | Enzastaurin: 1125 milligrams (mg) loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on non-enzyme inducing antiepileptic drugs (NEIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of progressive disease (PD), significant toxicity, withdrawal of consent, or other discontinuation criteria were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| bevacizumab | Drug | 10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles). |
|
| Enzyme-inducing antiepileptic drugs (EIAED) | Drug | Administered orally |
|
| Non-enzyme inducing antiepileptic drugs (NEIAED) | Drug | Administered orally |
|
| Registration to date of objective PD or death up to 66.56 months |
| To Evaluate Tumor Markers and Genes | Baseline and every cycle (4-week cycles) |
| Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | HRQoL was assessed with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) version 4. The instrument consists of 50 items with a 5-point rating scale for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The brain cancer-specific subscale consists of 23 items with a score ranging from 0-92. Higher scores in each subscale represent better QoL. Changes from baseline in the 4 core subscales are presented. | Baseline, Cycles 1-12 (4-week cycles) |
| United States |
| Odia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7. |
| Adverse Event |
|
| Withdrawal by Subject |
|
| BG001 | Enzastaurin + Bevacizumab (EIAED) | Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on EIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Enzastaurin + Bevacizumab (EIAED) | Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on EIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met. |
|
|
| Primary | Time to Progressive Disease (PD) | Defined as the time from registration to PD, death or date of last contact. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date. | All enrolled participants who received at least 1 dose of study drug. The number of participants censored are 7 for Enzastaurin + Bevacizumab NEIAED) group and 0 for Enzastaurin + Bevacizumab (EIAED) group. | Posted | Median | 95% Confidence Interval | months | Registration to PD, death or date of last contact up to 66.56 months |
|
|
|
| Secondary | Overall Response Rate (ORR) | Overall response is confirmed complete response (CR) + partial response (PR). CR is complete disappearance of all measurable and evaluable disease, no new lesions, and no evidence of non-evaluable disease. PR is ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions (or the 2 largest lesions), no progression of evaluable disease and no new lesions. ORR is calculated as (total number of participants with CR or PR from the start of registration until disease progression) / (the total number of participants treated)*100. | All enrolled participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Registration to date of objective PD or death up to 66.56 months |
|
|
|
| Secondary | To Evaluate Tumor Markers and Genes | Data were not collected for any participant due to low samples. | Posted | Baseline and every cycle (4-week cycles) |
|
|
| Secondary | Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | HRQoL was assessed with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) version 4. The instrument consists of 50 items with a 5-point rating scale for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The brain cancer-specific subscale consists of 23 items with a score ranging from 0-92. Higher scores in each subscale represent better QoL. Changes from baseline in the 4 core subscales are presented. | All enrolled participants who received at least 1 dose of study drug and had HRQoL assessed at baseline and in the end of Cycles 1-12. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycles 1-12 (4-week cycles) |
|
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) or Deaths (Safety) | Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Registration to study completion up to 67.56 months |
|
|
|
| 24 |
| 68 |
| 68 |
| 68 |
| EG001 | Enzastaurin + Bevacizumab (EIAED) | Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on enzyme inducing antiepileptic drugs (EIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles). Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles). Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met. | 4 | 13 | 13 | 13 |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastric infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood magnesium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Physical Well-Being Cycle 2 |
|
|
| Physical Well-Being Cycle 3 |
|
|
| Physical Well-Being Cycle 4 |
|
|
| Physical Well-Being Cycle 5 |
|
|
| Physical Well-Being Cycle 6 |
|
|
| Physical Well-Being Cycle 7 |
|
|
| Physical Well-Being Cycle 8 |
|
|
| Physical Well-Being Cycle 9 |
|
|
| Physical Well-Being Cycle 10 |
|
|
| Physical Well-Being Cycle 11 |
|
|
| Physical Well-Being Cycle 12 |
|
|
| Social/Family Well-Being Cycle 1 |
|
|
| Social/Family Well-Being Cycle 2 |
|
|
| Social/Family Well-Being Cycle 3 |
|
|
| Social/Family Well-Being Cycle 4 |
|
|
| Social/Family Well-Being Cycle 5 |
|
|
| Social/Family Well-Being Cycle 6 |
|
|
| Social/Family Well-Being Cycle 7 |
|
|
| Social/Family Well-Being Cycle 8 |
|
|
| Social/Family Well-Being Cycle 9 |
|
|
| Social/Family Well-Being Cycle 10 |
|
|
| Social/Family Well-Being Cycle 11 |
|
|
| Social/Family Well-Being Cycle 12 |
|
|
| Emotional Well-Being Cycle 1 |
|
|
| Emotional Well-Being Cycle 2 |
|
|
| Emotional Well-Being Cycle 3 |
|
|
| Emotional Well-Being Cycle 4 |
|
|
| Emotional Well-Being Cycle 5 |
|
|
| Emotional Well-Being Cycle 6 |
|
|
| Emotional Well-Being Cycle 7 |
|
|
| Emotional Well-Being Cycle 8 |
|
|
| Emotional Well-Being Cycle 9 |
|
|
| Emotional Well-Being Cycle 10 |
|
|
| Emotional Well-Being Cycle 11 |
|
|
| Emotional Well-Being Cycle 12 |
|
|
| Functional Well-Being Cycle 1 |
|
|
| Functional Well-Being Cycle 2 |
|
|
| Functional Well-Being Cycle 3 |
|
|
| Functional Well-Being Cycle 4 |
|
|
| Functional Well-Being Cycle 5 |
|
|
| Functional Well-Being Cycle 6 |
|
|
| Functional Well-Being Cycle 7 |
|
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| Functional Well-Being Cycle 8 |
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| Functional Well-Being Cycle 9 |
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| Functional Well-Being Cycle 10 |
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| Functional Well-Being Cycle 11 |
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| Functional Well-Being Cycle 12 |
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| ANCOVA |
P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. |
| 0.516 |
P-value is for Physical Well-Being Cycle 2. |
| Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.786 | P-value is for Physical Well-Being Cycle 3. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.1496 | P-value is for Physical Well-Being Cycle 4. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.8428 | P-value is for Physical Well-Being Cycle 5. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.7345 | P-value is for Physical Well-Being Cycle 6. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.8928 | P-value is for Physical Well-Being Cycle 7. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.7343 | P-value is for Physical Well-Being Cycle 8. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.8798 | P-value is for Social/Family Well-Being Cycle 1. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.6837 | P-value is for Social/Family Well-Being Cycle 2. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.7226 | P-value is for Social/Family Well-Being Cycle 3. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.641 | P-value is for Social/Family Well-Being Cycle 4. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.478 | P-value is for Social/Family Well-Being Cycle 5. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.9367 | P-value is for Social/Family Well-Being Cycle 6. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.5108 | P-value is for Social/Family Well-Being Cycle 7. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.8976 | P-value is for Social/Family Well-Being Cycle 8. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.8193 | P-value is for Emotional Well-Being Cycle 1. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.1695 | P-value is for Emotional Well-Being Cycle 2. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.4021 | P-value is for Emotional Well-Being Cycle 3. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.3603 | P-value is for Emotional Well-Being Cycle 4. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.5169 | P-value is for Emotional Well-Being Cycle 5. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.1642 | P-value is for Emotional Well-Being Cycle 6. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.6354 | P-value is for Emotional Well-Being Cycle 7. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.3517 | P-value is for Emotional Well-Being Cycle 8. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.7605 | P-value is for Functional Well-Being Cycle 1. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.3747 | P-value is for Functional Well-Being Cycle 2. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.8379 | P-value is for Functional Well-Being Cycle 3. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.1179 | P-value is for Functional Well-Being Cycle 4. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.7412 | P-value is for Functional Well-Being Cycle 5. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.3773 | P-value is for Functional Well-Being Cycle 6. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.7402 | P-value is for Functional Well-Being Cycle 7. | Superiority or Other (legacy) |
| ANCOVA | P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value. | 0.2671 | P-value is for Functional Well-Being Cycle 8. | Superiority or Other (legacy) |
| Deaths |
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