Trial Outcomes & Findings for Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin (NCT NCT02535312)
NCT ID: NCT02535312
Last Updated: 2025-10-29
Results Overview
Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
During the first cycle of treatment, up to 21 days
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
TRC102 50mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
6
|
14
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
6
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin
Baseline characteristics by cohort
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 Participants
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=4 Participants
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 Participants
TRC102 100 mg/dayPO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
n=6 Participants
TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
n=14 Participants
TRC102 50mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
61.5 years
n=7 Participants
|
66 years
n=5 Participants
|
68.5 years
n=4 Participants
|
74.5 years
n=21 Participants
|
70 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
14 participants
n=21 Participants
|
30 participants
n=8 Participants
|
|
ECOG performance status
0=Asymptomatic and fully active
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
ECOG performance status
1=Symptomatic; fully ambulatory; restricted in physically strenuous activity
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: During the first cycle of treatment, up to 21 daysDose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.
Outcome measures
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 Participants
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=4 Participants
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 Participants
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
n=6 Participants
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 days from start of treatment, up to 2 yearsThe maximum tolerated dose of TRC102 in combination with 500mg/m\^2 IV of Pemetrex and 60 or 75 mg/m\^2 IV of Cisplatin is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
Outcome measures
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=16 Participants
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
100 mg/day
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks post-treatmentPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 Participants
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=4 Participants
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 Participants
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
n=6 Participants
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
n=14 Participants
TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Number of Subject With Overall Response
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death from any cause, whichever occurs first, assessed up to at least 1 yearPopulation: Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=16 Participants
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=14 Participants
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
7.1 Months
Interval 1.4 to 14.4
|
3.8 Months
Interval 1.4 to 6.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to time of death from any cause, assessed up to at least 3 yearsPopulation: Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
Overall survival will be summarized as time from first protocol treatment until death from any cause, using the product-limit Kaplan-Meier estimator.
Outcome measures
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=16 Participants
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=14 Participants
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Overall Survival
|
20.0 Months
Interval 7.9 to
NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
15.9 Months
Interval 3.4 to
NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
—
|
—
|
—
|
Adverse Events
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
Serious events: 9 serious events
Other events: 14 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 participants at risk
TRC102 50 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=4 participants at risk
TRC102 75 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 participants at risk
TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
n=6 participants at risk
TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
n=14 participants at risk
TRC102 50mg PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease Progression
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Rhinovirus/Enterovirus Infection
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of lung
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 participants at risk
TRC102 50 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=4 participants at risk
TRC102 75 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
n=3 participants at risk
TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
|
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
n=6 participants at risk
TRC102 100 mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
|
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
n=14 participants at risk
TRC102 50mg PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 70 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
6/6 • Number of events 52 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
71.4%
10/14 • Number of events 89 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
LDH Increased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
nose bleed
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
66.7%
2/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear infection
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Flashing lights
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Unequal Pupil Dilation
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
discharge
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
drooping right eyelid
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
unequal pupil dilation
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 27 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
83.3%
5/6 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
28.6%
4/14 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dark stools
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Green Stool
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Helicobactor Pylori Gastritis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 49 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
4/6 • Number of events 33 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.7%
5/14 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema face
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
4/4 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 35 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
7/14 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Irritability
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
night sweats
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Laryngitis
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Oral Thrush
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
rhinorrhea
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
CrCl decrease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
decrease CrCl
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
decrecease CrCl
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
ALT decrease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
AST decrease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
42.9%
6/14 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Flashing lights -eye
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
LDH increase
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
LDH increased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
4/6 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
71.4%
10/14 • Number of events 58 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.7%
5/14 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
57.1%
8/14 • Number of events 40 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
blood bicarbonate decreased
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
decrease AST
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
decrease ALT
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
decrese ALT
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
elevated LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
elevated LDh
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
elevated troponin
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
increase LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
incresae LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
runny nose
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
total protein decrease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
transferrin saturation decrease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
4/6 • Number of events 27 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
28.6%
4/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Elevated LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
57.1%
8/14 • Number of events 75 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
3/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 25 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
42.9%
6/14 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
42.9%
6/14 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Increased LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Iron decrease
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
LDH Elevated
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Low Iron
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
decrease total protein
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
hyponatrmia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
increased LDH
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
low iron
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Numbness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
R. distal hand numbness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Right Hand Numbness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
increased shoulder pain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
numbness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
truncal instability
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
soft tissue growth on right upper latera
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
4/6 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Right Distal Hand numbness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
disorientation
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
slow walking/speech
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 25 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
35.7%
5/14 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 27 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
chest congestion
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
rhinnorhea
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Fungal rash
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndro
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
cellulitiis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
cellulittis
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
skin rash on scalp
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
sore on lower lip
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 26 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
21.4%
3/14 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
14.3%
2/14 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Sweats
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
superficial thrombophlebitis greater sap
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60