Lung Cancer, Non-Small Cell
Conditions
Keywords
Brain metastases from Non-Small Cell Lung Cancer, Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation
Brief summary
The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.
Interventions
DRUGHYCAMTIN, oral capsules
topotecan oral capsules 1.1 mg/m2
RADIATIONRadiation
Whole brain radiation
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC) * Must have received previous chemotherapy * Must be 18 years of age of greater * Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2 * At least 2 weeks must have elapsed since any surgery * At least 4 weeks must have elapsed since any radiation to a non-CNS site * Must have adequate bone marrow, renal, and live capacities * Women must be of non-childbearing potential or practice adequate birth control * Males must practice adequate methods of birth control * Must sign written informed consent
Exclusion criteria
* Previous whole brain radiation therapy * Prior treatment with topotecan * Investigational agent within 30 days or 5 half-live * Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib * Primary or secondary immunodeficiencies * Gastrointestinal conditions that affect GI absorption or motility * Uncontrolled emesis * Brain metastasis at time of initial diagnosis of NSCLC * History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer * Pregnant or intending to become pregnant or intending to father a baby * Any severe concurrent medical condition that could affect compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From the time of Randomization until the date of death due to any cause (up to 195 weeks) | Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | From the time of Randomization until the time of CR or PR (up to 75 weeks) | The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in \>=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses. |
| Time to Response (TTR) (CNS-radiologic) | From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks) | TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in \>=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses. |
| Time to Progression (TTP) (CNS-radiologic) | From the time of Randomization until the first documented sign of disease progression (up to 75 weeks) | TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants. |
| Time to Progression (TTP) (All Sites of Disease-radiologic) | From the time of Randomization until the first documented sign of disease progression (up to 75 weeks) | TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants. |
| Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Months 1 and 3 | Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG). |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE. |
| Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling. |
| Six-month Survival | Month 6 | Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored. |
| Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss). |
| Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling. |
| Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling. |
| Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE) | From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary. |
| Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks) | The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant Decreased to Low and Increased to High during the on-therapy period. |
| Lesion Assessment and Measurement | From the time of Randomization until the time of CR or PR (up to 75 weeks) | Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled Number of participants with a complete response (CR) or a partial response (PR) (central nervous system \[CNS\]-radiologic). |
| Brain Symptoms | Baseline, Month 1, and Month 3 | Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3. |
| Number of Participants Who Died or Progressed | From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks) | Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants. |
| Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, Month 1, and Month 3 | The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable). |
Countries
Canada, Hungary, Poland, Russia, Slovakia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemoradiation: Topotecan Plus WBRT Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator. | 236 |
| Radiation: WBRT Alone Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator. | 236 |
| Total | 472 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Investigator Decision | 4 | 6 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Ongoing | 4 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Withdrawal by Subject | 12 | 15 |
Baseline characteristics
| Characteristic | Radiation: WBRT Alone | Total | Chemoradiation: Topotecan Plus WBRT |
|---|---|---|---|
| Age, Continuous | 57.8 Years STANDARD_DEVIATION 8.65 | 58.6 Years STANDARD_DEVIATION 8.63 | 59.4 Years STANDARD_DEVIATION 8.56 |
| Race/Ethnicity, Customized African American/African Heritage (Her.) | 1 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized Asian & White | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Central/South Asian Heritage | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Japanese/East Asian Heritage/South East Asian Her. | 3 participants | 3 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 232 participants | 462 participants | 230 participants |
| Sex: Female, Male Female | 78 Participants | 162 Participants | 84 Participants |
| Sex: Female, Male Male | 158 Participants | 310 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 192 / 235 | 139 / 233 |
| serious Total, serious adverse events | 96 / 235 | 43 / 233 |
Outcome results
Primary
Overall Survival
Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.
Time frame: From the time of Randomization until the date of death due to any cause (up to 195 weeks)
Population: Intent-to-Treat (ITT) Population: all randomized participants. Participants were analyzed by the treatment to which they were randomized, even if this differed from the treatment they actually received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Overall Survival | 4.0 months |
| Radiation: WBRT Alone | Overall Survival | 3.6 months |
p-value: 0.186295% CI: [0.73, 1.07]Log Rank
Secondary
Brain Symptoms
Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3.
Time frame: Baseline, Month 1, and Month 3
Secondary
Lesion Assessment and Measurement
Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled Number of participants with a complete response (CR) or a partial response (PR) (central nervous system \[CNS\]-radiologic).
Time frame: From the time of Randomization until the time of CR or PR (up to 75 weeks)
Secondary
Number of Participants Who Died or Progressed
Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.
Time frame: From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Died or Progressed | 179 participants |
| Radiation: WBRT Alone | Number of Participants Who Died or Progressed | 161 participants |
Secondary
Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3
Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG).
Time frame: Months 1 and 3
Population: ITT Population. Only those participants who were assessed for the indicated sign and symptom at the indicated time point were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, severe, n=179, 188 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, moderate, n=179, 188 | 12 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, moderate, n=179, 188 | 17 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, severe, n=179, 188 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, severe, n=109, 111 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, none, n=109, 111 | 70 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, severe, n=179, 188 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, mild, n=109, 111 | 31 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, none, n=109, 111 | 69 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, moderate, n=109, 111 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, none, n=109, 111 | 73 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, severe, n=109, 111 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, none, n=179, 189 | 93 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, none, n=179, 188 | 153 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, mild, n=109, 111 | 28 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, mild, n=179, 188 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, mild, n=109, 111 | 28 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, moderate, n=179, 188 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, moderate, n=109, 111 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, severe, n=179, 188 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, none, n=179, 188 | 47 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, none, n=109, 111 | 89 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, severe, n=109, 111 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, mild, n=109, 111 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, none, n=179, 188 | 151 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, moderate, n=109, 111 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, moderate, n=109, 111 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, severe=109, 111 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, mild, n=179, 188 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, none, n=179, 188 | 96 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, mild, n=179, 189 | 71 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, mild, n=179, 188 | 58 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, moderate, n=179, 188 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, moderate, n=179, 188 | 22 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, moderate, 179, 189 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, severe, n=179, 188 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, severe, n=179, 188 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, none, n=109, 111 | 64 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, mild, n=179, 188 | 73 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, mild, n=109, 111 | 35 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, none, n=109, 110 | 94 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, moderate, n=109, 111 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, severe, n=109, 111 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, severe, n=109, 111 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, mild, n=109, 110 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, none, n=179, 188 | 103 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, severe, 179, 189 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, mild, n=179, 188 | 54 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, moderate, n=109, 110 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, moderate, n=179, 188 | 17 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, severe, n=179, 188 | 18 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, severe, n=179, 188 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, severe, n=109, 110 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, none, n=109, 111 | 72 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, none, n=179, 188 | 149 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, mild, n=109, 111 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, mild, n=109, 111 | 29 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, none, n=179, 188 | 150 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, moderate, n=109, 111 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, none, n=109, 111 | 69 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, mild, n=179, 188 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, mild, n=109, 111 | 51 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, none, n=179, 188 | 173 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, moderate, n=179, 188 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, mild, n=179, 188 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, moderate, n=179, 188 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, mild, n=109, 111 | 33 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, severe, n=179, 188 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, severe, n=179, 188 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, none, n=109, 110 | 108 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, moderate, n=109, 111 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, mild, n=109, 110 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, none, n=109, 110 | 99 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, moderate, n=109, 110 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, moderate, n=179, 188 | 41 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, severe, n=109, 110 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, mild, n=109, 110 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, none, n=179, 188 | 141 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, severe, n=109, 111 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, mild, n=179, 188 | 21 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, moderate, n=109, 110 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, moderate, n=179, 188 | 12 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, moderate, n=109, 111 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, severe, n=179, 188 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, severe, n=109, 110 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, none, n=179, 188 | 96 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, mild, n=109, 111 | 19 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, mild, n=179, 188 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, moderate, n=109, 111 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, severe, n=109, 111 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, none, n=179, 188 | 142 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, moderate, n=179, 188 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, mild, n=179, 188 | 26 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, mild, n=179, 188 | 55 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, moderate, n=179, 188 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, severe, n=179, 188 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, moderate, n=109, 111 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, severe, n=109, 111 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, severe, n=109, 111 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, none, n=109, 110 | 93 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, none, n=179, 188 | 112 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, moderate, n=179, 188 | 23 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, mild, n=179, 188 | 41 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, mild, n=109, 110 | 14 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, moderate, n=179, 188 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, none, n=179, 188 | 84 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, severe, n=179, 188 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, moderate, n=109, 110 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, none, n=109, 110 | 78 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, severe, n=179, 188 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, mild, n=109, 110 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, severe, n=179, 188 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, severe, n=109, 110 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, none, n=109, 111 | 28 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, none, n=109, 111 | 87 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, none, n=179, 188 | 90 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, none, n=109, 111 | 60 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, moderate, n=109, 110 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, mild, n=179, 188 | 55 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, severe, n=109, 110 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, none, n=179, 188 | 42 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, mild, n=179, 188 | 66 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, mild, n=179, 188 | 75 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, moderate, n=179, 188 | 25 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, moderate, n=179, 188 | 46 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, mild, n=109, 111 | 39 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, severe, n=179, 188 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, severe, n=179, 188 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, none, n=109, 111 | 28 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, none, n=109, 111 | 86 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, mild, n=109, 111 | 52 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, none, n=109, 111 | 50 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, moderate, n=109, 111 | 19 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, severe, n=109, 111 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, severe, n=109, 111 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, mild, n=109, 111 | 42 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, none, n=179, 188 | 107 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, moderate, n=179, 188 | 22 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, mild, n=179, 188 | 42 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, moderate, n=109, 111 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, moderate, n=179, 188 | 19 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, none, n=179, 188 | 101 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, severe, n=179, 188 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, severe, n=109, 111 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, none, n=108, 111 | 71 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, molderate, n=109, 111 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, mild, n=108, 111 | 27 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, none, n=179, 188 | 125 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, moderate, n=108, 111 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, mild, n=179, 188 | 53 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, severe, n=108, 111 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, mild, n=179, 188 | 38 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, severe, n=108, 111 | 4 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, none, n=109, 111 | 53 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, moderate, n=109, 111 | 14 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, none, n=179, 188 | 59 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, molderate, n=109, 111 | 16 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, severe, n=109, 111 | 7 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, none, n=179, 188 | 141 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, mild, n=179, 188 | 7 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, moderate, n=109, 111 | 6 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, none, n=179, 189 | 106 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, moderate, 179, 189 | 13 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, severe, 179, 189 | 2 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, mild, n=109, 111 | 41 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 3, severe, n=109, 111 | 3 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, none, n=179, 188 | 79 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, mild, n=179, 188 | 71 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, moderate, n=179, 188 | 30 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 1, severe, n=179, 188 | 8 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, none, n=109, 111 | 46 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, mild, n=109, 111 | 36 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, moderate, n=109, 111 | 18 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | PB/C, Month 3, severe, n=109, 111 | 11 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, mild, n=179, 188 | 72 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, moderate, n=179, 188 | 41 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 1, severe, n=179, 188 | 16 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, none, n=109, 111 | 34 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, mild, n=109, 111 | 37 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, moderate, n=109, 111 | 19 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Leg weakness, Month 3, severe, n=109, 111 | 21 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, none, n=179, 188 | 97 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, mild, n=179, 188 | 60 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, moderate, n=179, 188 | 18 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 1, severe, n=179, 188 | 13 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, none, n=109, 111 | 53 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, mild, n=109, 111 | 34 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Arm weakness, Month 3, severe, n=109, 111 | 8 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, none, n=179, 188 | 11 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, mild, n=179, 188 | 43 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, moderate, n=179, 188 | 25 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 1, severe, n=179, 188 | 9 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, none, n=109, 111 | 66 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, mild, n=109, 111 | 27 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofF/N, Month 3, moderate, n=109, 111 | 11 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, none, n=179, 188 | 137 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, mild, n=179, 188 | 40 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, moderate, n=179, 188 | 9 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 1, severe, n=179, 188 | 2 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, none, n=109, 110 | 78 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, mild, n=109, 110 | 22 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, moderate, n=109, 110 | 8 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | SD, Month 3, severe, n=109, 110 | 2 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, none, n=179, 188 | 148 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, mild, n=179, 188 | 32 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, moderate, n=179, 188 | 7 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 1, severe, n=179, 188 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, none, n=109, 110 | 71 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, mild, n=109, 110 | 29 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, moderate, n=109, 110 | 9 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Confusion, Month 3, severe, n=109, 110 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, mild, n=179, 188 | 41 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, moderate, n=179, 188 | 5 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 1, severe, n=179, 188 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, none, n=109, 110 | 78 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, mild, n=109, 110 | 25 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, moderate, n=109, 110 | 6 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | LofM, Month 3, severe, n=109, 110 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, none, n=179, 188 | 96 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, mild, n=179, 188 | 59 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, moderate, n=179, 188 | 26 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 1, severe, n=179, 188 | 7 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, none, n=109, 111 | 44 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, mild, n=109, 111 | 40 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, moderate, n=109, 111 | 15 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Drowsiness, Month 3, severe, n=109, 111 | 12 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, none, n=179, 188 | 142 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, mild, n=179, 188 | 36 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, moderate, n=179, 188 | 10 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 1, severe, n=179, 188 | 0 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, none, n=109, 111 | 73 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, mild, n=109, 111 | 29 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, moderate, n=109, 111 | 6 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Nausea, Month 3, severe, n=109, 111 | 3 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, none, n=179, 188 | 164 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, mild, n=179, 188 | 19 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, moderate, n=179, 188 | 4 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 1, severe, n=179, 188 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, none, n=109, 111 | 91 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, mild, n=109, 111 | 15 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, moderate, n=109, 111 | 3 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Vomiting, Month 3, severe=109, 111 | 2 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, none, n=179, 188 | 94 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, mild, n=179, 188 | 70 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, moderate, n=179, 188 | 21 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 1, severe, n=179, 188 | 3 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, none, n=109, 111 | 54 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, mild, n=109, 111 | 36 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, moderate, n=109, 111 | 14 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Dizziness, Month 3, severe, n=109, 111 | 7 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, none, n=179, 188 | 117 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, mild, n=179, 188 | 53 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, moderate, n=179, 188 | 16 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 1, severe, n=179, 188 | 2 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, none, n=109, 111 | 69 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, mild, n=109, 111 | 28 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, moderate, n=109, 111 | 10 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, mild, n=109, 111 | 18 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | VP, Month 3, severe, n=109, 111 | 4 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, none, n=179, 188 | 179 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, moderate, n=179, 188 | 2 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 1, severe, n=179, 188 | 0 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, none, n=109, 110 | 102 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, mild, n=109, 110 | 4 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, moderate, n=109, 110 | 3 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Seizures, Month 3, severe, n=109, 110 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, none, n=179, 188 | 138 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, mild, n=179, 188 | 29 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, moderate, n=179, 188 | 15 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 1, severe, n=179, 188 | 6 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, none, n=109, 111 | 85 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, mild, n=109, 111 | 19 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | L/AS, Month 3, severe, n=109, 111 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, none, n=179, 188 | 151 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, mild, n=179, 188 | 27 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, moderate, n=179, 188 | 9 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, moderate, n=109, 111 | 6 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, severe, n=109, 111 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, none, n=179, 188 | 109 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, mild, n=179, 188 | 48 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, moderate, n=179, 188 | 24 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 1, severe, n=179, 188 | 7 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, none, n=109, 110 | 71 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 1, severe, n=179, 188 | 1 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, severe, n=109, 110 | 4 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Heartburn, Month 3, none, n=109, 111 | 86 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, mild, n=109, 110 | 23 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | DS, Month 3, moderate, n=109, 110 | 12 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, none, n=179, 188 | 42 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, mild, n=179, 188 | 85 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, moderate, n=179, 188 | 44 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 1, severe, n=179, 188 | 17 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, none, n=109, 111 | 21 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, mild, n=109, 111 | 42 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, moderate, n=109, 111 | 32 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Tiredness, Month 3, severe, n=109, 111 | 16 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, none, n=179, 188 | 113 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, mild, n=179, 188 | 41 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, moderate, n=179, 188 | 29 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 1, severe, n=179, 188 | 5 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, none, n=108, 111 | 73 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, mild, n=108, 111 | 23 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | A/WG, Month 3, moderate, n=108, 111 | 11 participants |
| Radiation: WBRT Alone | Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 | Headache, Month 1, mild, n=179, 189 | 68 participants |
Secondary
Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)
The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in \>=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.
Time frame: From the time of Randomization until the time of CR or PR (up to 75 weeks)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Complete response | 23 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Partial response | 63 participants |
| Radiation: WBRT Alone | Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Complete response | 11 participants |
| Radiation: WBRT Alone | Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) | Partial response | 61 participants |
Secondary
Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary.
Time frame: From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)
Population: Modified ITT Population: all randomized participants who received at least one dose of randomized therapy. Participants were analyzed by the actual treatment received, even if this differed from the treatment to which they were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE) | AE | 204 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE) | SAE | 96 participants |
| Radiation: WBRT Alone | Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE) | AE | 148 participants |
| Radiation: WBRT Alone | Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE) | SAE | 43 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3
The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 160 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 124 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 76 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 45 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 44 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 21 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 21 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 151 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 26 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 128 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 76 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 14 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 47 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 36 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 9 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 20 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3
The investigator (per Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 62 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 25 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 85 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 43 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 126 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 17 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 141 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 146 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 127 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 74 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 55 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 38 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 23 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 23 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 14 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3
The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 219 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 180 | 171 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 102 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, not interfering, n=230, 228 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, not interfering, n=178, 180 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, not interfering, n=109, 107 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, interfering, n=230, 228 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, interfering, n=178, 180 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, interfering, n=109, 107 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, obtundation and stupor, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, obtundation and stupor, n=178, 180 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, obtundation and stupor, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, obtundation and stupor, n=178, 180 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 216 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, interfering, n=230, 228 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 180 | 169 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, obtundation and stupor, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 92 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, interfering, n=178, 180 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Baseline, not interfering, n=230, 228 | 9 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, obtundation and stupor, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 1, not interfering, n=178, 180 | 7 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, interfering, n=109, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 | Month 3, not interfering, n=109, 107 | 8 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3
The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 203 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 151 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 88 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 19 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 14 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, Grade 5, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 192 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 162 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 93 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 22 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, Grade 5, n=109, 107 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 15 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 11 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3
The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 99 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=177, 180 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=177, 180 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, absent, n=177, 180 | 165 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=229, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=177, 180 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=229, 228 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=177, 180 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=229, 228 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, Grade 5, n=109, 107 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, absent, n=229, 228 | 219 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, Grade 5, n=109, 107 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, absent, n=229, 228 | 214 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, absent, n=177, 180 | 171 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 101 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=229, 228 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=177, 180 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=229, 228 | 8 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=177, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=229, 228 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=177, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=177, 180 | 1 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3
The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 175 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 218 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 109 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 216 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 178 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 101 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 2 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3
The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 90 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 19 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 148 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 14 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 26 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 19 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 180 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 180 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 180 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 173 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 150 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 86 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 30 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 19 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 13 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 22 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 9 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 2 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3
The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 181 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 148 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 93 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 22 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 12 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 189 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 154 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 93 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 25 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 19 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 180 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 13 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=108, 107 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=108, 107 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 153 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 178 | 131 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, normal, n=108, 107 | 78 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 37 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 178 | 23 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=108, 107 | 17 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 27 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 178 | 13 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=108, 107 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 178 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 178 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 7 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 23 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=108, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 178 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 152 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 178 | 16 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 178 | 128 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 178 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, normal, n=108, 107 | 75 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=108, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 44 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=108, 107 | 9 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 178 | 28 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=108, 107 | 13 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 227 | 13 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 14 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 138 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=108, 107 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 227 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, normal, n=108, 107 | 85 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=108, 107 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=108, 107 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 227 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 227 | 172 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=108, 107 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 227 | 37 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=108, 107 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 147 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 227 | 178 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, normal, n=108, 107 | 76 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 227 | 22 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 13 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=108, 107 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 227 | 20 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 14 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 227 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=108, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 227 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=108, 107 | 12 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 227 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 178 | 14 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 227 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 178 | 156 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 178 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 97 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 227 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 227 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 178 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 178 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 227 | 199 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 178 | 162 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 227 | 13 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 227 | 201 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 94 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 178 | 9 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 227 | 7 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 178 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 227 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 178 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 227 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 178 | 1 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, 178, 179 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, normal, n=229, 228 | 206 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, normal, 178, 179 | 166 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 103 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=229, 228 | 13 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, 178, 179 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=229, 228 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=229, 228 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=229, 228 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, 178, 179 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, 178, 179 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=229, 228 | 12 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, normal, n=229, 228 | 198 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, 178, 179 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, normal, 178, 179 | 166 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 95 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=229, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=229, 228 | 17 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=229, 228 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, 178, 179 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 5 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3
The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, normal, n=229, 225 | 218 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 3, present, not interfering, n=109, 107 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 106 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, present, interfering, n=229, 225 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, present, not interfering, n=229, 225 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 1, present, interfering, n=177, 179 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 1, normal, n=177, 179 | 172 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 3, present, interfering, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 1, present, not interfering, n=177, 179 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 3, present, interfering, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, normal, n=229, 225 | 211 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 1, normal, n=177, 179 | 169 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, present, not interfering, n=229, 225 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 1, present, not interfering, n=177, 179 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 3, present, not interfering, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Baseline, present, interfering, n=229, 225 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 1, present, interfering, n=177, 179 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 102 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable).
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 211 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, impaired, n=230, 228 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 105 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 1, impaired, n=178, 180 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 1, not impaired, n=178, 180 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, impaired, n=109, 107 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, not impaired, n=230, 228 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, unable, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 169 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, unable, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, not impaired, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, unable, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, absent, n=230, 228 | 215 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 1, absent, n=178, 180 | 173 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, absent, n=109, 107 | 98 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 1, not impaired, n=178, 180 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, not impaired, n=109, 107 | 7 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, impaired, n=230, 228 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 1, impaired, n=178, 180 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Month 3, impaired, n=109, 107 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, unable, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 | Baseline, not impaired, n=230, 228 | 10 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3
The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss).
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 1, not interfering with function, n=178, 180 | 22 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month (M) 1, normal, n=178, 180 | 144 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 3, not interfering with function, n=109, 107 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 1, interfering with function, n=178, 180 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 3, interfering with function, n=109, 107 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline, permanent sensory loss, n=230, 228 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline, interfering with ADLs, n=230, 228 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 100 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month 1, interfering with ADLs, n=178, 180 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline (BL), normal, n=230, 228 | 197 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month 3, interfering with ADLs, n=109, 107 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | BL, not interfering with function, n=230, 228 | 26 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | BL, interfering with function, n=230, 228 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline, permanent sensory loss, n=230, 228 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | BL, interfering with function, n=230, 228 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 1, interfering with function, n=178, 180 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline (BL), normal, n=230, 228 | 192 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month (M) 1, normal, n=178, 180 | 159 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 94 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | BL, not interfering with function, n=230, 228 | 26 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 1, not interfering with function, n=178, 180 | 15 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 3, interfering with function, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Baseline, interfering with ADLs, n=230, 228 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month 1, interfering with ADLs, n=178, 180 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | Month 3, interfering with ADLs, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 | M 3, not interfering with function, n=109, 107 | 9 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 28 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 182 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 14 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 26 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 76 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 128 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 190 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 143 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 73 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 18 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 13 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 11 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 15 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 17 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 14 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 2 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 149 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 16 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 90 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 197 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 202 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 157 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 86 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 13 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 13 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 11 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 8 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 2 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 17 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 180 | 137 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 3 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 12 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 20 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 9 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 81 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 180 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 11 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 196 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 4, n=109, 107 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 189 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 180 | 145 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 80 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 19 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 180 | 15 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 11 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 16 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 180 | 19 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 11 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 180 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 180 | 1 participants |
Secondary
Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3
The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.
Time frame: Baseline, Month 1, and Month 3
Population: ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 203 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 153 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 93 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 13 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 10 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 6 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 5 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 2 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 3, n=178, 179 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, normal, n=230, 228 | 195 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 2, n=178, 179 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, normal, n=178, 179 | 159 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 4, n=230, 228 | 0 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, normal, n=109, 107 | 89 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 2, n=109, 107 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 1, n=230, 228 | 16 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 3, n=109, 107 | 3 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 1, n=178, 179 | 12 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 3, n=230, 228 | 5 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 3, Grade 1, n=109, 107 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Month 1, Grade 4, n=178, 179 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 | Baseline, Grade 2, n=230, 228 | 12 participants |
Secondary
Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range
The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant Decreased to Low and Increased to High during the on-therapy period.
Time frame: From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)
Population: Modified ITT Population. Only those participants with available laboratory values (indicated by the n in the category titles) were analyzed. Different participants may have been analyzed for different parameters; therefore, the overall number of participants analyzed reflects everyone in the Modified ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Creatinine clearance, ITH, n=159, 145 | 15 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Uric acid, ITH, n=159, 152 | 13 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Chloride, DTL, n=169, 171 | 32 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Basophils, DTL, n=215, 211 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Lactate dehydrogenase, CTN/NC, n=169, 168 | 117 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Basophils, CTN/NC, n=215, 211 | 186 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Creatinine clearance, DTL, n=159, 145 | 26 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Basophils, ITH, n=215, 211 | 25 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Lactate dehydrogenase, ITH, n=169, 168 | 47 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Eosinophils, DTL, n=214, 211 | 28 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Chloride, CTN/NC, n=169, 171 | 116 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Eosinophils, CTN/NC, n=214, 211 | 182 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Total protein, CTN/NC, n=171, 175 | 119 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Eosinophils, ITH, n=214, 211 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Total protein, DTL, n=171, 175 | 48 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Hematocrit, DTL, n=215, 212 | 98 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Total protein, ITH, n=171, 175 | 4 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Hematocrit, CTN/NC, n=215, 212 | 117 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Chloride, ITH, n=169, 171 | 22 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Hematocrit, ITH, n=215, 212 | 1 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Urea/blood urea nitrogen, DTL, n=178, 179 | 7 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Monocytes, DTL, n=216, 212 | 84 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Uric acid, CTN/NC, n=159, 152 | 125 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Monocytes, CTN/NC, n=216, 212 | 119 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Urea/blood urea nitrogen, CTN/NC, n=178, 179 | 139 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Monocytes, ITH, n=216, 212 | 54 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Creatinine clearance, CTN/NC, n=159, 145 | 121 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Red Blood Cell Count, DTL, n=216, 212 | 103 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Urea/blood urea nitrogen, ITH, n=178, 179 | 33 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Red Blood Cell Count, CTN/NC, n=216, 212 | 113 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Lactate dehydrogenase, DTL, n=169, 168 | 8 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Red Blood Cell Count, ITH, n=216, 212 | 0 participants |
| Chemoradiation: Topotecan Plus WBRT | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Uric acid, DTL, n=159, 152 | 21 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Red Blood Cell Count, ITH, n=216, 212 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Creatinine clearance, ITH, n=159, 145 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Lactate dehydrogenase, ITH, n=169, 168 | 40 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Uric acid, CTN/NC, n=159, 152 | 134 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Chloride, DTL, n=169, 171 | 21 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Chloride, CTN/NC, n=169, 171 | 144 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Creatinine clearance, DTL, n=159, 145 | 9 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Creatinine clearance, CTN/NC, n=159, 145 | 134 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Lactate dehydrogenase, DTL, n=169, 168 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Lactate dehydrogenase, CTN/NC, n=169, 168 | 127 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Total protein, DTL, n=171, 175 | 36 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Total protein, CTN/NC, n=171, 175 | 137 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Total protein, ITH, n=171, 175 | 2 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Urea/blood urea nitrogen, DTL, n=178, 179 | 4 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Urea/blood urea nitrogen, CTN/NC, n=178, 179 | 152 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Urea/blood urea nitrogen, ITH, n=178, 179 | 24 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Uric acid, DTL, n=159, 152 | 12 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Uric acid, ITH, n=159, 152 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Basophils, DTL, n=215, 211 | 1 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Basophils, CTN/NC, n=215, 211 | 200 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Basophils, ITH, n=215, 211 | 10 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Eosinophils, DTL, n=214, 211 | 12 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Eosinophils, CTN/NC, n=214, 211 | 191 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Eosinophils, ITH, n=214, 211 | 8 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Hematocrit, DTL, n=215, 212 | 38 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Hematocrit, CTN/NC, n=215, 212 | 169 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Hematocrit, ITH, n=215, 212 | 6 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Monocytes, DTL, n=216, 212 | 17 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Monocytes, CTN/NC, n=216, 212 | 161 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Monocytes, ITH, n=216, 212 | 37 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Red Blood Cell Count, DTL, n=216, 212 | 38 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Red Blood Cell Count, CTN/NC, n=216, 212 | 171 participants |
| Radiation: WBRT Alone | Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range | Chloride, ITH, n=169, 171 | 6 participants |
Secondary
Six-month Survival
Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Six-month Survival | 36 percentage of participants |
| Radiation: WBRT Alone | Six-month Survival | 28 percentage of participants |
Secondary
Time to Progression (TTP) (All Sites of Disease-radiologic)
TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.
Time frame: From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Time to Progression (TTP) (All Sites of Disease-radiologic) | 8.0 weeks |
| Radiation: WBRT Alone | Time to Progression (TTP) (All Sites of Disease-radiologic) | 7.7 weeks |
Secondary
Time to Progression (TTP) (CNS-radiologic)
TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase \>=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase \>=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.
Time frame: From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Time to Progression (TTP) (CNS-radiologic) | 9.7 weeks |
| Radiation: WBRT Alone | Time to Progression (TTP) (CNS-radiologic) | 9.7 weeks |
Secondary
Time to Response (TTR) (CNS-radiologic)
TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in \>=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.
Time frame: From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)
Population: ITT Population. Only those participants with a CR, PR, or a missing response were assessed. TTR was analyzed with censoring for extended loss to follow-up to account for two or more missed response assessments before a TTR event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemoradiation: Topotecan Plus WBRT | Time to Response (TTR) (CNS-radiologic) | 8.0 weeks |
| Radiation: WBRT Alone | Time to Response (TTR) (CNS-radiologic) | 8.1 weeks |