Trial Outcomes & Findings for Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer (NCT NCT03944941)
NCT ID: NCT03944941
Last Updated: 2026-06-02
Results Overview
The study will be declared promising if, after the 37th PFS event, the hazard ratio is less than 0.758.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 years
Results posted on
2026-06-02
Participant Flow
Participant milestones
| Measure |
Arm I (Avelumab)
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>\>
\>\>\>
\>\>
\>\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\>\> \>\>\>
\>\>
\>\>\> Avelumab: Given IV\>\>
\>\>\>
\>\>
\>\>\> Cetuximab: Given IV
|
|---|---|---|
|
Initial
STARTED
|
30
|
30
|
|
Initial
COMPLETED
|
28
|
29
|
|
Initial
NOT COMPLETED
|
2
|
1
|
|
Crossover
STARTED
|
9
|
0
|
|
Crossover
COMPLETED
|
4
|
0
|
|
Crossover
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Avelumab)
n=28 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>\>\>
\>\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 Participants
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\>\>\> \>\>\> Avelumab: Given IV\>\>\>
\>\>\> Cetuximab: Given IV
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
n=9 Participants
|
72 years
n=27 Participants
|
72 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
54 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=9 Participants
|
29 Participants
n=27 Participants
|
56 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
HIV status
Negative
|
28 Participants
n=9 Participants
|
29 Participants
n=27 Participants
|
57 Participants
n=267 Participants
|
|
HIV status
Positive
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Disease extent
Locoregional only
|
15 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
ECOG PS
0
|
9 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
ECOG PS
1
|
19 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
ECOG PS
2
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
PD-L1 status
Negative
|
7 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
PD-L1 status
Positive
|
21 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
43 Participants
n=267 Participants
|
|
Primary tumor site
Anogenital
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Primary tumor site
Extremities
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Primary tumor site
Head and neck
|
25 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
48 Participants
n=267 Participants
|
|
Primary tumor site
Trunk
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Primary tumor site
Other
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Metastatic disease
No
|
11 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Metastatic disease
Yes
|
17 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
|
Disease extent
Distant only
|
8 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Disease extent
Locoregional 1 distant
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 yearsThe study will be declared promising if, after the 37th PFS event, the hazard ratio is less than 0.758.
Outcome measures
| Measure |
Arm I (Avelumab)
n=28 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 Participants
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Cetuximab: Given IV
|
|---|---|---|
|
Prolonging of Progression Free Survival (PFS) on Avelumab and Cetuximab Compared to Avelumab Alone
|
3.0 months
Interval 2.7 to 13.6
|
11.1 months
Interval 7.6 to
There are not enough events to calculate the upper bound of the confidence interval.
|
SECONDARY outcome
Timeframe: Up to 2 years post treatment, up to 4 yearsA patient will be declared a success for RR if they achieve a partial response (PR) or better on two consecutive evaluations (at least 8 weeks apart). The number of successes will be divided by the number of evaluable patients to estimate the RR for each treatment arm and exact 95% confidence intervals will be calculated based on the properties of the binomial distribution.
Outcome measures
| Measure |
Arm I (Avelumab)
n=28 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 Participants
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Cetuximab: Given IV
|
|---|---|---|
|
Confirmed Objective Response Rate (RR)
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years post treatment, up to 4 yearsThe CBR will be estimated as the number of successes divided by the total number of evaluable patients. An exact 95% confidence interval will be constructed around the CBR using the properties of the binomial distribution.
Outcome measures
| Measure |
Arm I (Avelumab)
n=28 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 Participants
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Cetuximab: Given IV
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
9 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 yearsWill explore the PFS for those patients that crossover to combination therapy (avelumab + cetuximab) after progressing on avelumab alone (baseline time being the time of crossover). The Kaplan-Meier method will be used to calculate a median PFS as well as a 95% confidence interval.
Outcome measures
| Measure |
Arm I (Avelumab)
n=9 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Cetuximab: Given IV
|
|---|---|---|
|
PFS in Patients Who Have Progressed on Avelumab Alone
|
11.3 months
Interval 5.8 to
There are not enough events to calculate the upper bound of the confidence interval.
|
—
|
SECONDARY outcome
Timeframe: Time between enrollment and or death, assessed up to 2 years post treatment, up to 4 yearsThe Kaplan-Meier method will be used to calculate a median OS as well as a 95% confidence interval.
Outcome measures
| Measure |
Arm I (Avelumab)
n=28 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 Participants
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Cetuximab: Given IV
|
|---|---|---|
|
Overall Survival (OS)
|
35.8 months
Interval 18.6 to
There are not enough events to calculate the upper bound of the confidence interval.
|
NA months
Interval 25.2 to
There are not enough events to calculate the median and the upper bound of the confidence interval.
|
SECONDARY outcome
Timeframe: Up to 30 days post treatment, up to 4 yearsWill be described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized in a tabular setting by treatment arm.
Outcome measures
| Measure |
Arm I (Avelumab)
n=28 Participants
Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 Participants
Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Avelumab: Given IV\>
\>\>
\>\>
\>\>
\>
\>\>
\>\>
\>\> Cetuximab: Given IV
|
|---|---|---|
|
Incidence of Grade 3+ Adverse Events
Acneiform rash
|
0 Participants
|
6 Participants
|
|
Incidence of Grade 3+ Adverse Events
Infusion-related reaction
|
0 Participants
|
6 Participants
|
|
Incidence of Grade 3+ Adverse Events
Hypomagnesemia
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Syncope
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Pain of skin
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Hypotension
|
1 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Sinus bradycardia
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Diarrhea
|
0 Participants
|
2 Participants
|
|
Incidence of Grade 3+ Adverse Events
Anaphylaxis
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Skin infection
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Lower GI hemorrhage
|
0 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Anemia
|
1 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
Lymphocyte count decreased
|
1 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
Colitis
|
1 Participants
|
1 Participants
|
|
Incidence of Grade 3+ Adverse Events
Dysphagia
|
1 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
Fatigue
|
1 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
ALT increased
|
2 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
AST increased
|
2 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
Acute kidney injury
|
1 Participants
|
0 Participants
|
|
Incidence of Grade 3+ Adverse Events
Dyspnea
|
1 Participants
|
1 Participants
|
Adverse Events
Arm I (Avelumab)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm II (Avelumab, Cetuximab)
Serious events: 1 serious events
Other events: 29 other events
Deaths: 1 deaths
Arm I (Avelumab) Crossover
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm I (Avelumab)
n=28 participants at risk
Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 participants at risk
Cetuximab: Given IV
|
Arm I (Avelumab) Crossover
n=9 participants at risk
Avelumab: Given IV Cetuximab: Given IV
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
Other adverse events
| Measure |
Arm I (Avelumab)
n=28 participants at risk
Avelumab: Given IV
|
Arm II (Avelumab, Cetuximab)
n=29 participants at risk
Cetuximab: Given IV
|
Arm I (Avelumab) Crossover
n=9 participants at risk
Avelumab: Given IV Cetuximab: Given IV
|
|---|---|---|---|
|
Psychiatric disorders
Hallucinations
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Psychiatric disorders
Insomnia
|
14.3%
4/28 • Number of events 8 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 27 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Psychiatric disorders
Restlessness
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.6%
1/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Hematuria
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.6%
1/28 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Urinary retention
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
2/28 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
5/28 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 30 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
4/28 • Number of events 17 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 17 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 17 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 9 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.6%
1/28 • Number of events 9 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
20.7%
6/29 • Number of events 41 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.6%
1/28 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 13 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 15 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.6%
1/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 17 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
4/28 • Number of events 32 • Up to 2 years post treatment, up to 4 years
|
79.3%
23/29 • Number of events 181 • Up to 2 years post treatment, up to 4 years
|
55.6%
5/9 • Number of events 23 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.7%
3/28 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
17.9%
5/28 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
20.7%
6/29 • Number of events 49 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
35.7%
10/28 • Number of events 33 • Up to 2 years post treatment, up to 4 years
|
24.1%
7/29 • Number of events 26 • Up to 2 years post treatment, up to 4 years
|
33.3%
3/9 • Number of events 13 • Up to 2 years post treatment, up to 4 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 13 • Up to 2 years post treatment, up to 4 years
|
|
Psychiatric disorders
Delirium
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
10.7%
3/28 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 12 • Up to 2 years post treatment, up to 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
3.6%
1/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
2/28 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Endocrine disorders
Hyperthyroidism
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
2/28 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 18 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Cataract
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Dry eye
|
3.6%
1/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Eye disorders - Other, specify
|
3.6%
1/28 • Number of events 9 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Eye pain
|
3.6%
1/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Eyelid function disorder
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Floaters
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Vision decreased
|
3.6%
1/28 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
21.4%
6/28 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
20.7%
6/29 • Number of events 34 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Number of events 14 • Up to 2 years post treatment, up to 4 years
|
31.0%
9/29 • Number of events 24 • Up to 2 years post treatment, up to 4 years
|
44.4%
4/9 • Number of events 15 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 34 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Gastritis
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
2/28 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 17 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 18 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 22 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Proctitis
|
3.6%
1/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Chills
|
10.7%
3/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Edema face
|
7.1%
2/28 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Edema limbs
|
14.3%
4/28 • Number of events 15 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 8 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Facial pain
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Fatigue
|
42.9%
12/28 • Number of events 84 • Up to 2 years post treatment, up to 4 years
|
27.6%
8/29 • Number of events 59 • Up to 2 years post treatment, up to 4 years
|
66.7%
6/9 • Number of events 36 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Fever
|
10.7%
3/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Flu like symptoms
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Generalized edema
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Injection site reaction
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Localized edema
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Neck edema
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 9 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
General disorders and administration site conditions
Pain
|
28.6%
8/28 • Number of events 18 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
44.4%
4/9 • Number of events 22 • Up to 2 years post treatment, up to 4 years
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Abdominal infection
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Bone infection
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 22 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Enterocolitis infectious
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Folliculitis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
10.7%
3/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 8 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 14 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Nail infection
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Otitis media
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 13 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Thrush
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Tooth infection
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.3%
4/28 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
31.0%
9/29 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
17.9%
5/28 • Number of events 14 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 28 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
17.9%
5/28 • Number of events 24 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
4/28 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
17.2%
5/29 • Number of events 30 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Blood bilirubin increased
|
7.1%
2/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Creatinine increased
|
28.6%
8/28 • Number of events 32 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Investigations - Other, specify
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
7/28 • Number of events 29 • Up to 2 years post treatment, up to 4 years
|
24.1%
7/29 • Number of events 27 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 24 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Platelet count decreased
|
7.1%
2/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
Weight loss
|
25.0%
7/28 • Number of events 11 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 8 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.6%
1/28 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.7%
3/28 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
8/28 • Number of events 44 • Up to 2 years post treatment, up to 4 years
|
20.7%
6/29 • Number of events 40 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.9%
5/28 • Number of events 8 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
3.6%
1/28 • Number of events 15 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
7/28 • Number of events 18 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 15 • Up to 2 years post treatment, up to 4 years
|
55.6%
5/9 • Number of events 14 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
4/28 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
6/28 • Number of events 27 • Up to 2 years post treatment, up to 4 years
|
48.3%
14/29 • Number of events 96 • Up to 2 years post treatment, up to 4 years
|
55.6%
5/9 • Number of events 26 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.1%
9/28 • Number of events 14 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
33.3%
3/9 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.7%
3/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 27 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
1/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.1%
2/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
2/28 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 15 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 24 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.6%
1/28 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
6.9%
2/29 • Number of events 23 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
3.6%
1/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Number of events 12 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
44.4%
4/9 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
20.7%
6/29 • Number of events 55 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 16 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Memory impairment
|
3.6%
1/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Neuralgia
|
3.6%
1/28 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
2/28 • Number of events 8 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Seizure
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Syncope
|
7.1%
2/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Number of events 6 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Psychiatric disorders
Confusion
|
7.1%
2/28 • Number of events 3 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
3.6%
1/28 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Vascular disorders
Hypertension
|
28.6%
8/28 • Number of events 17 • Up to 2 years post treatment, up to 4 years
|
13.8%
4/29 • Number of events 39 • Up to 2 years post treatment, up to 4 years
|
22.2%
2/9 • Number of events 10 • Up to 2 years post treatment, up to 4 years
|
|
Vascular disorders
Hypotension
|
17.9%
5/28 • Number of events 9 • Up to 2 years post treatment, up to 4 years
|
10.3%
3/29 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
33.3%
3/9 • Number of events 4 • Up to 2 years post treatment, up to 4 years
|
|
Vascular disorders
Lymphedema
|
3.6%
1/28 • Number of events 2 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 12 • Up to 2 years post treatment, up to 4 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 7 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/29 • Up to 2 years post treatment, up to 4 years
|
11.1%
1/9 • Number of events 5 • Up to 2 years post treatment, up to 4 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/28 • Up to 2 years post treatment, up to 4 years
|
3.4%
1/29 • Number of events 1 • Up to 2 years post treatment, up to 4 years
|
0.00%
0/9 • Up to 2 years post treatment, up to 4 years
|
Additional Information
Dr. Dan P. Zandberg
University of Pittsburgh Medical Center Hillman Cancer Center
Phone: 412-864-7955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place