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| ID | Type | Description | Link |
|---|---|---|---|
| 1R42CA171552-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: ABI-009 100 mg/week | Experimental | Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
|
| Phase 1: ABI-009 200 mg/week | Experimental | Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
|
| Phase 1: ABI-009 100 mg 2×/week | Experimental | Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks |
|
| Phase 1: ABI-009 300 mg/week | Experimental | Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
|
| Phase 1: ABI-009 400 mg/week | Experimental | Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-009 | Drug | ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009 | The primary endpoint of the Phase 1 study is DLT following intravesical administration of ABI-009 in patients with BCG refractory or recurrent nonmuscle-invasive transitional cell carcinoma (TCC) of the bladder to identify maximum deliverable dose (MDD). Systemic DLT will be defined as any grade systemic toxicity using the NCI CTCAE version 4.0. Local dose limiting toxicity was defined as grade 3 or 4 bladder toxicity (hematuria, dysuria, urinary retention, urinary frequency/urgency, or bladder spasms) using the NCI CTCAE version 4.0. | Duration of treatment (6 weeks) plus 30 days follow up (up to 2.5 months) |
| Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine | The primary objective of the Phase 2 study is to evaluate the utility (potential for clinical efficacy) of ABI-009 in combination with gemcitabine in the treatment of BCG refractory or recurrent nonmuscle-invasive TCC of the bladder. Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy. | End of Study [EOS, 3 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 | Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy. | End of Study [EOS, 3 months] |
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Inclusion Criteria:
Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).
Age >18 and must be able to read, understand, and sign informed consent
Performance Status: ECOG 0, 1, and 2 (See Appendix III)
Hematologic inclusion within 2 weeks of start of treatment
Hepatic inclusion within 2 weeks of entry
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James McKiernan, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| Vanderbilt University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: ABI-009 100 mg/Week | Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| FG001 | Phase 1: ABI-009 200 mg/Week | Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| FG002 | Phase 1: ABI-009 100 mg 2×/Week | Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks |
| FG003 | Phase 1: ABI-009 300 mg/Week | Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| FG004 | Phase 1: ABI-009 400 mg/Week | Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| FG005 | Phase 2: ABI-009 200 mg/Week + Gemcitabine 2000 mg/Week | ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Dose Level 1 (Weeks 1-10) |
| |||||||||||||
| Phase 1: Dose Level 2/2b (Wks 11-29) |
| |||||||||||||
| Phase 1: Dose Level 3 (Weeks 30-47) |
| |||||||||||||
| Phase 1: Dose Level 4 (Weeks 48-77) |
| |||||||||||||
| Phase 2 (Weeks 206-252) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: ABI-009 100 mg/Week | Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| BG001 | Phase 1: ABI-009 200 mg/Week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009 | The primary endpoint of the Phase 1 study is DLT following intravesical administration of ABI-009 in patients with BCG refractory or recurrent nonmuscle-invasive transitional cell carcinoma (TCC) of the bladder to identify maximum deliverable dose (MDD). Systemic DLT will be defined as any grade systemic toxicity using the NCI CTCAE version 4.0. Local dose limiting toxicity was defined as grade 3 or 4 bladder toxicity (hematuria, dysuria, urinary retention, urinary frequency/urgency, or bladder spasms) using the NCI CTCAE version 4.0. | All Phase 1 patients who received at least 1 treatment. | Posted | Count of Participants | Participants | Duration of treatment (6 weeks) plus 30 days follow up (up to 2.5 months) |
|
From the signing of the informed consent through the 6-week induction treatment period and the 30-day follow-up period (up to 2.5 months). An additional 4 months for patients who received 3 additional monthly maintenance treatments (up to 6.5 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: ABI-009 100 mg/Week | Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Berta Grigorian | Aadi Bioscience | 818-416-8378 | bgrigorian@aadibio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2016 | Mar 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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The phase 1 dose-escalation portion used the 3+3 dose escalation rule. Initially 3 patients will be treated. If none develops DLT following the third weekly instillation, the dose can be escalated. If only 1 of the first 3 patients develops DLT, then an additional 3 patients will be treated at that dose. At any dose level, if 2 or more cases develop DLT, the prior dose will be defined as the MDD once 6 patients have been treated at this level with less than 2 patients experiencing a DLT.
In phase 2, up to 29 patients will receive intravesical ABI-009 and gemcitabine using the Simon 2-stage design: initially, there will be only 10 patients enrolled with a rejection rule that only if there are 2 or more positive responses will the study proceed to further enrollment of the next 19 patients.
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|
| Phase 2: ABI-009 400 mg/week + Gemcitabine 2000 mg/week | Experimental | ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks |
|
|
|
| Gemcitabine | Drug | Gemcitabine is administered after ABI-009 in the Phase 2 study. |
|
| Nashville |
| Tennessee |
| 37232 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
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|
Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks
| BG002 | Phase 1: ABI-009 100 mg 2x/Week | Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks |
| BG003 | Phase 1: ABI-009 300 mg/Week | Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| BG004 | Phase 1: ABI-009 400 mg/Week | Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks |
| BG005 | Phase 2, Efficacy | ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Phase 1: ABI-009 200 mg/Week | Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm. |
| OG002 | Phase 1: ABI-009 100 mg 2×/Week | Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm. |
| OG003 | Phase 1: ABI-009 300 mg/Week | Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm. |
| OG004 | Phase 1: ABI-009 400 mg/Week | Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm. |
|
|
|
| Primary | Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine | The primary objective of the Phase 2 study is to evaluate the utility (potential for clinical efficacy) of ABI-009 in combination with gemcitabine in the treatment of BCG refractory or recurrent nonmuscle-invasive TCC of the bladder. Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy. | Analysis population includes all patients who have completed the planned 6 treatment cycles and have 6 week follow up cystoscopy data available | Posted | Count of Participants | Participants | End of Study [EOS, 3 months] |
|
|
|
| Secondary | Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 | Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy. | Analysis population includes all patients who have completed the planned 6 treatment cycles and have 6 week follow up cystoscopy data available. | Posted | Count of Participants | Participants | End of Study [EOS, 3 months] |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Phase 1: ABI-009 200 mg/Week | Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Phase 1: ABI-009 100 mg 2×/Week | Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Phase 1: ABI-009 300 mg/Week | Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Phase 1: ABI-009 400 mg/Week | Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | 4 | 0 | 4 | 3 | 4 |
| EG005 | Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week | ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks | 0 | 6 | 0 | 6 | 6 | 6 |
| Urinary tract infection | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Penis Lesion/rash | Reproductive system and breast disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Increased frequency and urgency of urination | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Abnormal urine analysis | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Inguinal and thigh pruritus | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Decreased absolute neutrophil | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Decreased white blood cell | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Elevated bilirubin | Hepatobiliary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Worsening of congestive heart failure | Cardiac disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Worsening of chronic kidney disease | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Worsening of edema of extremities | Musculoskeletal and connective tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Mucositis | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Fever | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Malaise | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
Not provided
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| D001749 |
| Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |