Trial Outcomes & Findings for Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease (NCT NCT02469701)
NCT ID: NCT02469701
Last Updated: 2020-02-17
Results Overview
Assessment of tumor response by scan 12 weeks post the first dose of Nivolumab and approximately every 12 weeks after. Post progression by RECIST a 1 month confirmatory scan will be done and that will be the indicator of Progression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 5 years.
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Nivolumab With Ablation
3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.
Either cryoablation or thermal ablation may be performed as per standard institutional policies
nivolumab and ablation
As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance .
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease
Baseline characteristics by cohort
| Measure |
Nivolumab With Ablation
n=10 Participants
3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.
Either cryoablation or thermal ablation may be performed as per standard institutional policies
nivolumab and ablation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
64.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years.Population: Number of patients that were not known to Progress
Assessment of tumor response by scan 12 weeks post the first dose of Nivolumab and approximately every 12 weeks after. Post progression by RECIST a 1 month confirmatory scan will be done and that will be the indicator of Progression.
Outcome measures
| Measure |
Nivolumab With Ablation
n=10 Participants
3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.
Either cryoablation or thermal ablation may be performed as per standard institutional policies
nivolumab and ablation
|
|---|---|
|
Response Rate of the Combination of Ablation and the PD-1 Inhibitor Nivolumab for Patients With Non-small Cell Lung Cancer (NSCLC) Who Have Progressed Following at Least 1 Prior Chemotherapy Regimen for Metastatic or Locally Advanced Disease.
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1 Participants
|
Adverse Events
Nivolumab With Ablation
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab With Ablation
n=10 participants at risk
3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.
Either cryoablation or thermal ablation may be performed as per standard institutional policies
nivolumab and ablation
As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance .
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|---|---|
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Investigations
Sepsis, Pneumonia, Respiratory Failure
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Sepsis
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Myocardial Infarction, Respiratory Failure
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Spinal Fracture
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Fracture Rib
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Atrial Fibrillation
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
Other adverse events
| Measure |
Nivolumab With Ablation
n=10 participants at risk
3mg/kg IV over 60 minutes on Day 1 +/- 3 days every 2 weeks until progression for a maximum of 2 years.
Either cryoablation or thermal ablation may be performed as per standard institutional policies
nivolumab and ablation
As of amendment # 7 submitted to sites November 17, 2017, the dosing for Nivolumab per the FDA guidance was amended to a flat dose of 240mg IV Q2 weeks. As of amendment #8 sent to sites February 22, 2017 the dose of Nivolumab was updated to 3 mg/kg with a maximum dose of 240 mg for patients with weights that would correlate to exceed that dose instead of a flat dose secondary to the standard institutional practice and the FDA guidance .
|
|---|---|
|
Investigations
agitation
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
AKI
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Albumin
|
50.0%
5/10 • Number of events 5 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
ALK PHOS (ALP)
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
allergic rhinitis
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
ALT
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Anorexia
|
60.0%
6/10 • Number of events 6 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
anxiety
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
apnea
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
arthralgia (r shoulder, knee)
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Ascites
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Aspiration
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
AST
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Reproductive system other : BPH
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
CA
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
chills/sweats
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
confusion
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Congestive heart failure
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Constipation
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
cough (productive cough)
|
40.0%
4/10 • Number of events 4 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
CR
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Dehydration
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Delirium
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
depression
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Diarrhea
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Dizziness
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Dry eyes
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Dry mouth
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Dry skin
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Dysphagia
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
dyspnea
|
40.0%
4/10 • Number of events 4 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
edema (limbs, bilateral lower extremity)
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Eye disorder other (double vision)
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Fatigue
|
60.0%
6/10 • Number of events 6 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
fever
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Fracture (spinal, rib)
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
gait disturbance
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Glucose
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Headache
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
HGB/ANEMIA
|
80.0%
8/10 • Number of events 8 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
HTN
|
50.0%
5/10 • Number of events 5 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Hypotension
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Hypothyroidism
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
hypoxia
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Infection and Infestations other ( sinus)
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
INR
|
40.0%
4/10 • Number of events 4 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
insomnia
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
K
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Lethargy
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Lymph
|
50.0%
5/10 • Number of events 5 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Malaise
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
MG
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
muscle weakness
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Musculoskeletal other (soreness, trap spasm, impaired balance )
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
|
100.0%
10/10 • Number of events 10 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Nausea
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Neuropathy
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Pain -non cardiac various locations
|
100.0%
10/10 • Number of events 10 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Palpitations
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Paresthesia
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
pericardial effusion
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Pleural effusion
|
50.0%
5/10 • Number of events 5 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
PLT
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
pneumonia (infection other)
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
PO4 /PHOS
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Pruritus
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Pulmonary edema
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Rash
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Renal and Urinary disorders other(difficulty urinating )
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Respiratory other (Hemoptysis)
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Restlessness
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Sore throat
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
tachycardia
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Thromboembolic event
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Tinnitus (ear)
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Tremor
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Troponin I
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
urinary frequency
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Vomit
|
30.0%
3/10 • Number of events 3 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
weight gain
|
10.0%
1/10 • Number of events 1 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Weight loss
|
50.0%
5/10 • Number of events 5 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
|
Investigations
Wheezing
|
20.0%
2/10 • Number of events 2 • AEs and SAEs were required to be captured and reported from when the patient signed consent to 4 weeks post last dose of drug or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first.
SAE capture includes a total of 6 initial medwatches effecting 5 patients (some gradable events within the medwtach may have occurred with multiple patients as outlined below in the affected/at risk table). Additional reports submitted to the FDA include follow up information regarding discharge, change of admission terms and administrative changes made to the report previously submitted.
|
Additional Information
Kristen M. Mitchell, CCRP
Brown University Oncology Research Group
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place