Trial Outcomes & Findings for Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma (NCT NCT01964755)
NCT ID: NCT01964755
Last Updated: 2019-09-23
Results Overview
Complete Response (CR) rate in study participants to protocol therapy. Response will be assessed via CT Scan and bone marrow aspirate/biopsy, if applicable. Complete response criteria include: * Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to Non Hodgkin's Lymphoma (NHL); * All lymph nodes and tumor masses disappeared or regressed to normal size (≤ 1.5 cm in their greatest transverse diameters for nodes \> 1.5 cm before therapy); * Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter (GTD) before treatment must have decreased to ≤ 1 cm in their GTD after treatment, or by more than 75% bin the sum of the products of the greatest diameters (SPD); * No new sites of disease.
TERMINATED
PHASE2
6 participants
About 21 days
2019-09-23
Participant Flow
Participant milestones
| Measure |
Chemotherapy + Antiviral-Based Therapy
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Cycle 2
|
5
|
|
Overall Study
Cycle 3
|
4
|
|
Overall Study
Cycle 4
|
4
|
|
Overall Study
Cycle 5
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Chemotherapy + Antiviral-Based Therapy
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma
Baseline characteristics by cohort
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: About 21 daysPopulation: Participants who started at least one cycle of protocol therapy.
Complete Response (CR) rate in study participants to protocol therapy. Response will be assessed via CT Scan and bone marrow aspirate/biopsy, if applicable. Complete response criteria include: * Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to Non Hodgkin's Lymphoma (NHL); * All lymph nodes and tumor masses disappeared or regressed to normal size (≤ 1.5 cm in their greatest transverse diameters for nodes \> 1.5 cm before therapy); * Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter (GTD) before treatment must have decreased to ≤ 1 cm in their GTD after treatment, or by more than 75% bin the sum of the products of the greatest diameters (SPD); * No new sites of disease.
Outcome measures
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Rate of Complete Response to Protocol Therapy
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants receiving at least one cycle of protocol therapy.
Rate of overall survival of study participants at one year since initiation of protocol therapy. Overall survival (OS) will be measured from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up will be censored at date of last contact (censored observation). Kaplan-Meier estimate of overall survival at one-year.
Outcome measures
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
One-year Rate of Overall Survival
|
83.3 percentage of participants
Interval 27.3 to 97.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants receiving at least one cycle of protocol therapy.
Rate of failure-free survival of study participants one-year after start of protocol therapy. Failure-free survival (FFS) will be measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time will be censored at the last documented date of failure-free status. Kaplan-Meier estimate of failure-free survival at one-year.
Outcome measures
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
One-Year Rate of Failure-Free Survival (FFS)
|
37.5 percentage of participants
Interval 1.1 to 80.8
|
SECONDARY outcome
Timeframe: Through Duration of Protocol Therapy, Up to six 21-day cycles (+/- 7 days)Population: Participants starting at least once cycle of protocol therapy. Participants experiencing toxicity are tabulated by grade (gr.) of toxicity.
Rate of adverse events, serious adverse events or other toxicities related to protocol therapy in study participants.
Outcome measures
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Rate of Toxicity Related to Protocol Therapy
Patients w/Toxicity Definitely Treatment-Related
|
0 Participants
|
|
Rate of Toxicity Related to Protocol Therapy
Gr. 4 Toxicity Probably/Possibly Treatment-Related
|
1 Participants
|
|
Rate of Toxicity Related to Protocol Therapy
Gr. 3 Toxicity Probably/Possibly Treatment-Related
|
4 Participants
|
|
Rate of Toxicity Related to Protocol Therapy
Gr. 2 Toxicity Probably/Possibly Treatment-Related
|
6 Participants
|
|
Rate of Toxicity Related to Protocol Therapy
Gr. 1 Toxicity Probably/Possibly Treatment-Related
|
6 Participants
|
SECONDARY outcome
Timeframe: From Baseline Up to 1 Year Post-TherapyPopulation: Per protocol, evaluable participants are those who receive 3 or more cycles of treatment. Three of these participants were HIV-positive. Before therapy, HIV viral load was undetectable in 2 participants.
Measurement of HIV Viral Load in positive subjects before, during and after protocol therapy to assess the effect of protocol therapy on immune reconstitution or exhaustion.
Outcome measures
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=3 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
HIV Viral Load in Positive Subjects Before, During and After Protocol Therapy
Before Therapy
|
333 copies/ml
|
|
HIV Viral Load in Positive Subjects Before, During and After Protocol Therapy
During Therapy
|
NA copies/ml
HIV viral load undetectable in study participants.
|
|
HIV Viral Load in Positive Subjects Before, During and After Protocol Therapy
After Therapy
|
NA copies/ml
HIV viral load undetectable in study participants.
|
SECONDARY outcome
Timeframe: From Baseline Up to 1 Year Post-TherapyPopulation: Per protocol, evaluable participants are those who receive 3 or more cycles of treatment. Three of these participants were HIV-positive. Data for T-cell subset levels (CD4, CD8) were available during and after for two of these three participants.
Measurement of T-cell subset levels (CD4, CD8) in peripheral blood before, during and after protocol therapy to assess the effect of protocol therapy on immune re-constitution or exhaustion.
Outcome measures
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=3 Participants
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy
CD4 count, Before Therapy
|
328 cells/mm^3
Standard Deviation 164.05
|
|
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy
CD4 count, During Therapy
|
285 cells/mm^3
Standard Deviation 124.58
|
|
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy
CD4 count, After Therapy
|
323.5 cells/mm^3
Standard Deviation 178.90
|
|
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy
CD8 count, Before Therapy
|
1246 cells/mm^3
Standard Deviation 668.86
|
|
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy
CD8 count, During Therapy
|
1006 cells/mm^3
Standard Deviation 741.05
|
|
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy
CD8 count, After Thaerapy
|
1006 cells/mm^3
Standard Deviation 741.05
|
SECONDARY outcome
Timeframe: From Baseline Up to 1 year Post-TherapyPopulation: Serum EBV viral load levels were below the limit of detection in subjects before therapy. Data were not collected during and after therapy.
Measurement of Epstein Barr Virus (EBV) viral load in peripheral blood in study participants before, after treatment, and during surveillance in order to correlate the presence of with tumor load and disease status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline Up to 1 year Post-TherapyPopulation: This outcome measure was added via amendment for new participants enrolled after December 2016 however; no new participants were enrolled. No data were collected for this outcome measure.
Measurement of EBV reactivation in circulating peripheral blood memory B-cells before and after treatment with chemotherapy/Zidovudine (ZDV) in order to assess the drug effect on EBV latency.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: This outcome measure was added via amendment for new participants enrolled after December 2016 however; no new participants were enrolled. No data were collected for this outcome measure.
Determine baseline tumor EBV gene expression profile to assess viral thymidine kinases. (BXLF1/vTK and BGLF4/PK), EBV latency pattern (I, II or III) and lytic phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Duration of Response to Protocol Therapy Until Disease Progression, Up to 5 yearsPopulation: This outcome measure was added via amendment for new participants enrolled after December 2016 however; no new participants were enrolled. No data were collected for this outcome measure.
Measurement of immune activation markers and inflammation in peripheral blood in response to treatment and EBV reactivation.
Outcome measures
Outcome data not reported
Adverse Events
Chemotherapy + Antiviral-Based Therapy
Serious adverse events
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 participants at risk
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
16.7%
1/6 • Number of events 2 • 4 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
Chemotherapy + Antiviral-Based Therapy
n=6 participants at risk
Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy per study protocol:
* Chemotherapy: Up to 6 cycles, 21 days each:
* Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1;
* Rituximab: 375mg/m2 (optional) IV on Day 1;
* Methotrexate: 3.5 gm/m2 IV on Day 2;
* Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses;
* Antiviral-Based Therapy
* Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses;
* Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses.
Doxorubicin: Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
Methotrexate: Methotrexate administered starting on Day 2.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
6/6 • Number of events 23 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 4 • 4 years
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 5 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Number of events 4 • 4 years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 4 • 4 years
|
|
Infections and infestations
Conjunctivitis infective
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Number of events 6 • 4 years
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 4 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 3 • 4 years
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • 4 years
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Flushing
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 3 • 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
General disorders
Headache
|
33.3%
2/6 • Number of events 4 • 4 years
|
|
Reproductive system and breast disorders
Hiccups
|
50.0%
3/6 • Number of events 6 • 4 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
6/6 • Number of events 47 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 2 • 4 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
50.0%
3/6 • Number of events 4 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
3/6 • Number of events 9 • 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
4/6 • Number of events 10 • 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
2/6 • Number of events 4 • 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
4/6 • Number of events 18 • 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 3 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
3/6 • Number of events 6 • 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Reproductive system and breast disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Investigations
INR increased
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
General disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Blood and lymphatic system disorders
Leukocytes
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Investigations
Lymphocyte count decreased
|
50.0%
3/6 • Number of events 12 • 4 years
|
|
General disorders
Malaise
|
33.3%
2/6 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
3/6 • Number of events 12 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 16 • 4 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 5 • 4 years
|
|
General disorders
Oral pain
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Nervous system disorders
Personality change
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
General disorders
Pharyngolaryngeal pain
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Seborrheic Dermatitis
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Infections and infestations
Genital Herpes
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 7 • 4 years
|
|
General disorders
Weight loss
|
16.7%
1/6 • Number of events 1 • 4 years
|
|
Investigations
White blood cell decreased
|
66.7%
4/6 • Number of events 13 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place