Trial Outcomes & Findings for Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma (NCT NCT00233948)
NCT ID: NCT00233948
Last Updated: 2015-04-01
Results Overview
DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
4 weeks from start of treatment, up to 2 years
Results posted on
2015-04-01
Participant Flow
Participant milestones
| Measure |
Phase I: Dose Level 1
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
Oral Nelfinavir at 4250mg bid.
|
Phase II
Oral Nelfinavir at 3000mg bid
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
4
|
12
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
4
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level 1
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
Oral Nelfinavir at 4250mg bid.
|
Phase II
Oral Nelfinavir at 3000mg bid
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
Baseline characteristics by cohort
| Measure |
Phase I
n=17 Participants
Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
|
Phase II
n=12 Participants
Oral Nelfinavir at 3000 mg bid
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
63 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks from start of treatment, up to 2 yearsPopulation: All patients receiving treatment were evaluated for DLT.
DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid
Outcome measures
| Measure |
Phase I: Dose Level I
n=4 Participants
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
n=3 Participants
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
n=3 Participants
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
n=3 Participants
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
n=4 Participants
Oral Nelfinavir at 4250mg bid.
|
|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) (Phase I)
|
0 participants with DLTs
|
0 participants with DLTs
|
0 participants with DLTs
|
0 participants with DLTs
|
0 participants with DLTs
|
PRIMARY outcome
Timeframe: 4 weeks from start of treatment, up to 2 yearsPopulation: All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.
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. If PK analysis of 3 patients treated at 4250 mg bid and 3 patients at 3000 mg bid confirms that the first dose area under the curve and Cmax of nelfinavir does not increase appreciably at doses greater than 1875 mg BID then 3000 mg BID will be deemed the MTD.
Outcome measures
| Measure |
Phase I: Dose Level I
n=17 Participants
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
Oral Nelfinavir at 4250mg bid.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) (Phase I)
|
3000 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: After 3 cycles of treatment, up to 2 years.Population: Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Phase I: Dose Level I
n=12 Participants
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
Oral Nelfinavir at 4250mg bid.
|
|---|---|---|---|---|---|
|
Overall Response Rate (Phase II)
|
1 participants
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I: Dose Level I
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I: Dose Level II
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Dose Level III
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Dose Level IV
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Dose Level V
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase II
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Dose Level I
n=4 participants at risk
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
n=3 participants at risk
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
n=3 participants at risk
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
n=3 participants at risk
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
n=4 participants at risk
Oral Nelfinavir at 4250mg bid.
|
Phase II
n=12 participants at risk
Oral Nelfinavir at 3000 mg bid
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Phase I: Dose Level I
n=4 participants at risk
Oral Nelfinavir at 1250mg bid.
|
Phase I: Dose Level II
n=3 participants at risk
Oral Nelfinavir at 1500mg bid.
|
Phase I: Dose Level III
n=3 participants at risk
Oral Nelfinavir at 2125mg bid.
|
Phase I: Dose Level IV
n=3 participants at risk
Oral Nelfinavir at 3000mg bid.
|
Phase I: Dose Level V
n=4 participants at risk
Oral Nelfinavir at 4250mg bid.
|
Phase II
n=12 participants at risk
Oral Nelfinavir at 3000 mg bid
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 6 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 6 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
8/12 • Number of events 54 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Premature ventricular contractions
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 6 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
58.3%
7/12 • Number of events 8 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
4/12 • Number of events 14 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
4/4 • Number of events 13 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 6 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 11 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
83.3%
10/12 • Number of events 48 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 5 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
41.7%
5/12 • Number of events 6 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
6/12 • Number of events 8 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
9/12 • Number of events 21 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 5 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
4/12 • Number of events 9 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchitis
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection, Bacterial (COH)
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 10 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
2/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 9 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
41.7%
5/12 • Number of events 11 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 7 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
4/12 • Number of events 11 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
50.0%
2/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 14 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypercholesterolemia
|
25.0%
1/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 25 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
50.0%
2/4 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lipase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
8/12 • Number of events 20 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 13 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
4/12 • Number of events 10 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 12 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 5 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
6/12 • Number of events 46 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
8/12 • Number of events 17 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
41.7%
5/12 • Number of events 11 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
4/12 • Number of events 5 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 6 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 8 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 7 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
58.3%
7/12 • Number of events 18 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
6/12 • Number of events 11 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
6/12 • Number of events 7 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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 upper limb
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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)
Myelodysplasia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 6 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
25.0%
1/4 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 4 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
3/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded over a period of 5 years, 2 months.
"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%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 desquamating
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"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 disorder
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
2/12 • Number of events 3 • Adverse events were recorded over a period of 5 years, 2 months.
"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 hyperpigmentation
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 7 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Adverse events were recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"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 recorded over a period of 5 years, 2 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/12 • Adverse events were recorded over a period of 5 years, 2 months.
"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