Trial Outcomes & Findings for Tiragolumab and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases (NCT NCT05746481)
NCT ID: NCT05746481
Last Updated: 2026-01-22
Results Overview
The proportion of patients that require salvage radiation therapy to the CNS (within 18 weeks from study initiation). Salvage radiation therapy is radiation treatment given for suspected recurrent malignant disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Up to 18 weeks
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Single Treatment Arm
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tiragolumab and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases
Baseline characteristics by cohort
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Age, Continuous
|
68.33 years
n=270 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
PRIMARY outcome
Timeframe: Up to 18 weeksPopulation: Enrolled patients
The proportion of patients that require salvage radiation therapy to the CNS (within 18 weeks from study initiation). Salvage radiation therapy is radiation treatment given for suspected recurrent malignant disease.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Rate of Initiation of Salvage Radiation Therapy to Central Nervous System (CNS)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsAdverse Events and Serious Adverse Events per Common Terminology Criteria for Adverse Events CTCAE v5.0, at least possibly related to trial treatment.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Adverse Events Related to Treatment
Fatigue
|
2 participants
|
|
Adverse Events Related to Treatment
Hypophosphatemia
|
1 participants
|
|
Adverse Events Related to Treatment
Hypothyroidism
|
1 participants
|
|
Adverse Events Related to Treatment
infusion related reaction
|
1 participants
|
|
Adverse Events Related to Treatment
Lipase increased
|
2 participants
|
|
Adverse Events Related to Treatment
Lung infection
|
1 participants
|
|
Adverse Events Related to Treatment
Lymphocyte count decreased
|
3 participants
|
|
Adverse Events Related to Treatment
Mucositis oral
|
1 participants
|
|
Adverse Events Related to Treatment
non-papular rash
|
1 participants
|
|
Adverse Events Related to Treatment
Platelet count decreased
|
1 participants
|
|
Adverse Events Related to Treatment
Pruritus
|
1 participants
|
|
Adverse Events Related to Treatment
Rash acneiform
|
1 participants
|
|
Adverse Events Related to Treatment
Serum amylase increased
|
1 participants
|
|
Adverse Events Related to Treatment
Sinus tachycardia
|
1 participants
|
|
Adverse Events Related to Treatment
Thyroid stimulating hormone increased
|
1 participants
|
|
Adverse Events Related to Treatment
White blood cell decreased
|
2 participants
|
|
Adverse Events Related to Treatment
Alkaline phosphatase increased
|
1 participants
|
|
Adverse Events Related to Treatment
Anemia
|
3 participants
|
|
Adverse Events Related to Treatment
Anorexia
|
1 participants
|
|
Adverse Events Related to Treatment
Aspartate aminotransferase increased
|
1 participants
|
|
Adverse Events Related to Treatment
Chronic Kidney Disease
|
1 participants
|
|
Adverse Events Related to Treatment
Creatinine increased
|
1 participants
|
|
Adverse Events Related to Treatment
Eczema
|
2 participants
|
|
Adverse Events Related to Treatment
Edema limbs
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Treated patients.
Number of patients with brain metastases that experience a Complete or Partial Response per RANO-BM. RANO Criteria: Complete Response (CR):disappearance of all enhancing disease (measurable and non-measurable), sustained for at least 4 weeks, stable or improved non-enhancing FLAIR/T2W lesions, no new lesions; clinical features - no corticosteroids (physiological replacement doses allowed) clinically stable or improved. Partial Response (PR): 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks no progression of non-measurable disease stable or improved non-enhancing FLAIR/T2W lesions no new lesions; clinical features stable or reduced corticosteroids (compared to baseline) clinically stable or improved. Progressive disease (PD): either one of: any new lesions at least 20% relative and 5 mm absolute increase of SOD of target lesions compared to smallest SOD ever recorded. Stable disease (SD): not meeting criteria for PD or PR.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Brain Metastasis Response Rate (BMRR)
Complete Response
|
0 Participants
|
|
Brain Metastasis Response Rate (BMRR)
Partial Response
|
2 Participants
|
|
Brain Metastasis Response Rate (BMRR)
Stable Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Treated patients evaluable for response.
Response per RANO Criteria: Complete Response (CR):disappearance of all enhancing disease (measurable and non-measurable), sustained for at least 4 weeks, stable or improved non-enhancing FLAIR/T2W lesions, no new lesions; clinical features \- no corticosteroids (physiological replacement doses allowed) clinically stable or improved. Partial Response (PR): 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks no progression of nonmeasurable disease stable or improved non-enhancing FLAIR/T2W lesions no new lesions; clinical features stable or reduced corticosteroids (compared to baseline) clinically stable or improved.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Response Per RANO Criteria
Complete Response (CR)
|
0 Participants
|
|
Response Per RANO Criteria
Partial Response (PR)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Treated patients evaluable for radiologic response.
The proportion of participants experiencing Complete or Partial Response assessed using RECIST v1.1. Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Single Treatment Arm
n=2 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Response Per RECIST
Complete Response (CR)
|
0 Participants
|
|
Response Per RECIST
Partial Response (PR)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Treated patients evaluable for response.
The length of time from start of treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Progression-free Survival (PFS) - Per Patient
Patient 1
|
18.8 months
|
|
Progression-free Survival (PFS) - Per Patient
Patient 2
|
10.8 months
|
|
Progression-free Survival (PFS) - Per Patient
Patient 3
|
13.5 months
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All enrolled patients.
The median duration of time from start of treatment until death from any cause.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Median was not reached as no event was observed in the any patients.
|
SECONDARY outcome
Timeframe: Within 18 weeks of study initiationPopulation: No patients received salvage radiation therapy to the CNS.
The length of time during and after treatment and after after initiation of salvage radiation therapy (XRT) that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Treated patients who completed surgery.
Tumor Proportion Score (TPS) indicates protein expression by measuring the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
PD-L1 Tumor Proportion Score (TPS)
Patient 1
|
90 percentage of PD-L1 positive tumor cells
|
|
PD-L1 Tumor Proportion Score (TPS)
Patient 2
|
1 percentage of PD-L1 positive tumor cells
|
|
PD-L1 Tumor Proportion Score (TPS)
Patient 3
|
0 percentage of PD-L1 positive tumor cells
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Treated patients evaluable for response.
The median length of time from start of treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Progression-free Survival (PFS)
|
13.48 months
Interval 10.58 to
Upper bound of 95% CI not reached due to low number of patients/events observed.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All enrolled patients.
The duration of time from start of treatment until death from any cause, or the last clinical follow-up.
Outcome measures
| Measure |
Single Treatment Arm
n=3 Participants
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Overall Survival (OS) - Per Patient
Patient 1
|
18.8 months
|
|
Overall Survival (OS) - Per Patient
Patient 2
|
10.6 months
|
|
Overall Survival (OS) - Per Patient
Patient 3
|
14.4 months
|
Adverse Events
Single Treatment Arm
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Treatment Arm
n=3 participants at risk
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Nervous system disorders
Stroke
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
Other adverse events
| Measure |
Single Treatment Arm
n=3 participants at risk
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Tiragolumab: Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
Atezolizumab: Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
Pemetrexed: Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
Carboplatin: Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Gastrointestinal disorders
Belching
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
General disorders
Chills
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Dysarthria
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
General disorders
Edema limbs
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
General disorders
Fever
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Vascular disorders
Flu like symptoms
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Injury, poisoning and procedural complications
Fracture
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
infusion related reaction
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Eye disorders
left eye flashes of light
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Lipase increased
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Muscle weakness right-sided
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
non-papular rash
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
General disorders
pain - right shoulder
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Paresthesia
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
petechial rash (hands)
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Serum amylase increased
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Thrush
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Thyroid stimulating hormone increased
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
Weight gain
|
33.3%
1/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Adverse Events data were collected for up to 12 months. All-Cause Mortality data was collected for up to 24 months. Per-patient Survival presented in Outcome Measure 7 is defined as "The length of time from start of treatment that patients remain still alive". No patients have had the event of death while they were on study. Participants were monitored/assessed for All-Cause Mortality for up to 24 months (while on study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place