Trial Outcomes & Findings for Daratumumab for the Treatment of Patients With AL Amyloidosis (NCT NCT02841033)
NCT ID: NCT02841033
Last Updated: 2021-05-07
Results Overview
Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L, a PR is dFLC reduction by \>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \>100 mg/L. \* "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
3 months
Results posted on
2021-05-07
Participant Flow
Participant milestones
| Measure |
Daratumumab
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daratumumab for the Treatment of Patients With AL Amyloidosis
Baseline characteristics by cohort
| Measure |
Daratumumab
n=22 Participants
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
16 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
|
Time since initial diagnosis
|
48 months
n=99 Participants
|
|
Prior therapies
|
2 lines of treatment
n=99 Participants
|
|
Time since last plasma cell-directed treatment
|
9 months
n=99 Participants
|
|
dFLC
|
80.7 mg/L
n=99 Participants
|
|
Number of organ systems involved
|
2 organ systems
n=99 Participants
|
|
NYHA Class II or III
|
11 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L, a PR is dFLC reduction by \>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \>100 mg/L. \* "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.
Outcome measures
| Measure |
Daratumumab
n=22 Participants
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
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|---|---|
|
Assess the Number of Patients Who Respond to Treatment
Complete Response (CR)
|
5 Participants
|
|
Assess the Number of Patients Who Respond to Treatment
Very Good Partial Response (VGPR)
|
13 Participants
|
|
Assess the Number of Patients Who Respond to Treatment
Partial Response (PR)
|
2 Participants
|
|
Assess the Number of Patients Who Respond to Treatment
Stable Disease (SD)
|
1 Participants
|
|
Assess the Number of Patients Who Respond to Treatment
Progressive Disease (PD)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of months from study drug initiation to starting another treatment
Outcome measures
| Measure |
Daratumumab
n=22 Participants
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Time to Next Treatment
<12 months
|
3 Participants
|
|
Time to Next Treatment
>12 months
|
1 Participants
|
|
Time to Next Treatment
No further treatment
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 monthsNumber of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L; and a PR is dFLC reduction by \>50%. \* "dFLC" is difference in involved and uninvolved serum free light-chain levels
Outcome measures
| Measure |
Daratumumab
n=22 Participants
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria
Complete Response, Very Good Partial Response, or Partial Response
|
20 Participants
|
|
Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria
Stable Disease or Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 19 evaluable patients with cardiac and/or renal involvement.
Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (\>30% and \>300 ng/L decrease in patients with a baseline NT-proBNP \>650 ng/L; and/or NYHA class response (\> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by \> 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline
Outcome measures
| Measure |
Daratumumab
n=19 Participants
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Assess Organ Responses Based on Standard Criteria Included in Protocol
|
14 Participants
|
Adverse Events
Daratumumab
Serious events: 11 serious events
Other events: 22 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Daratumumab
n=22 participants at risk
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Atrial fibrillation
|
18.2%
4/22 • Number of events 5 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
CK increased
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Colitis
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
CPK increased
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Fever
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage - melena
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Heart failure
|
13.6%
3/22 • Number of events 5 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Hematuria
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Myocardial infarction (NSTEMI)
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Renal and urinary disorders - other, UTI sepsis
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Sepsis
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Syncope
|
9.1%
2/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Urine output decreased
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
Other adverse events
| Measure |
Daratumumab
n=22 participants at risk
Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.
Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
|
|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Atrial fibrillation
|
18.2%
4/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Chest pain - cardiac
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Heart failure
|
13.6%
3/22 • Number of events 6 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Cardiac disorders
Palpitations
|
9.1%
2/22 • Number of events 5 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Ear and labyrinth disorders
Ear pain
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Ear and labyrinth disorders
Hearing loss
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Ear and labyrinth disorders
Tinnitus
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Ear and labyrinth disorders
Vertigo
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Endocrine disorders
Endocrine disorder - other, specify: TSH elevated
|
13.6%
3/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Endocrine disorders
Hyperthyroidism
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Blurred vision
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Cataract
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Conjunctivitis
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Dry eye
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye disorders - other, specify: cloudiness
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye disorders - other, specify: obstructive tear duct
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye disorders - other, specify: redness
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye disorders - other, specify: scleral abrasian
|
4.5%
1/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye disorders - other, specify: Scotoma
|
4.5%
1/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye disorders - other, specify: subconjunctival hemorrhage
|
31.8%
7/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Eye infection
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Floaters
|
4.5%
1/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Eye disorders
Watering eyes
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Abdominal distention
|
31.8%
7/22 • Number of events 16 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
36.4%
8/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Bloating
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
8/22 • Number of events 16 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Dental caries
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Diarrhea
|
86.4%
19/22 • Number of events 68 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: inguinal hernia
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: black stool
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: broken tooth
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: H. pylori
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: Tooth extraction
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: ulcer - Left lateral tongue
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other, specify: viral gastroenteritis
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Nausea
|
59.1%
13/22 • Number of events 35 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Oral pain
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
8/22 • Number of events 11 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Chest pain
|
4.5%
1/22 • Number of events 5 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Chest pain - cardiac
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Chest pain - non cardiac
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Chills
|
18.2%
4/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Edema limbs
|
45.5%
10/22 • Number of events 12 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Fatigue
|
72.7%
16/22 • Number of events 33 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Fever
|
31.8%
7/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Flu like symptoms
|
9.1%
2/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Gait disturbance
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
General disorders
Localized Edema
|
13.6%
3/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Immune system disorders
Immune system disorders - other, specify: lymphadenopathy
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Laryngitis
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Pharyngitis
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Rhinitis infective
|
36.4%
8/22 • Number of events 17 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Sinusitis
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Tooth infection
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
11/22 • Number of events 21 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Infections and infestations
Vaginal infection
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Injury, poisoning and procedural complications
Bruising
|
45.5%
10/22 • Number of events 14 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
2/22 • Number of events 6 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Alanine aminotransferase increased (ALTT)
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Alkaline phosphatase increased
|
45.5%
10/22 • Number of events 24 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Anemia
|
68.2%
15/22 • Number of events 42 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Anorexia
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Aspartate aminotransferase increased (AST)
|
36.4%
8/22 • Number of events 18 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Cardiac troponin I increased
|
45.5%
10/22 • Number of events 30 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Cholesterol high
|
59.1%
13/22 • Number of events 32 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
CPK increased
|
45.5%
10/22 • Number of events 31 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Creatinine Increased
|
77.3%
17/22 • Number of events 67 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Cystitis non-infective
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Investigations - other, specify: Lactate dehydrogenase elevated
|
9.1%
2/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Lymphocyte count decreased
|
81.8%
18/22 • Number of events 76 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Neutrophil count decreased
|
22.7%
5/22 • Number of events 14 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Platelet count decreased
|
45.5%
10/22 • Number of events 18 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Serum amylase increased
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Total bilirubin increased
|
27.3%
6/22 • Number of events 27 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Weight gain
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
Weight loss
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Investigations
White blood cell decreased
|
27.3%
6/22 • Number of events 11 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.8%
7/22 • Number of events 13 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
22.7%
5/22 • Number of events 11 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
4/22 • Number of events 11 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
27.3%
6/22 • Number of events 6 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
63.6%
14/22 • Number of events 23 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
72.7%
16/22 • Number of events 61 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
59.1%
13/22 • Number of events 26 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
11/22 • Number of events 27 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.6%
3/22 • Number of events 7 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
22.7%
5/22 • Number of events 8 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.8%
7/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
36.4%
8/22 • Number of events 29 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Metabolic and nutrition disorders - other, specify: increased appetite
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Metabolic and nutrition disorders - other, specify: iron deficiency
|
36.4%
8/22 • Number of events 9 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Metabolic and nutrition disorders - other, specify: Type 2 diabetes mellitus
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Metabolism and nutrition disorders
Metabolic and nutrition disorders - other, specify: vitamin B12 deficiency
|
4.5%
1/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
31.8%
7/22 • Number of events 12 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
54.5%
12/22 • Number of events 28 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Fever
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other, specify: Dupuytren's contracture
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other, specify: Restless legs
|
18.2%
4/22 • Number of events 9 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
63.6%
14/22 • Number of events 41 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
31.8%
7/22 • Number of events 15 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
45.5%
10/22 • Number of events 15 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - other, specify: basal cell carcinoma on sternum
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Concentration impairment
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Dizziness
|
50.0%
11/22 • Number of events 24 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Dysphagia
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Headache
|
63.6%
14/22 • Number of events 47 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Memory impairment
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Autonomic Postural Hypotension
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Paresthesia
|
36.4%
8/22 • Number of events 15 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Nervous system disorders
Tremor
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Agitation
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Confusion (forgetfullness)
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Depression
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Insomnia
|
54.5%
12/22 • Number of events 15 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Irritability
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Psychiatric disorders
Mania
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Chronic kidney disease
|
50.0%
11/22 • Number of events 30 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Hematuria
|
22.7%
5/22 • Number of events 8 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Nocturia
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Urinary frequency
|
22.7%
5/22 • Number of events 6 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Urinary tract pain
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Renal and urinary disorders
Urinary urgency
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Reproductive system and breast disorders
Genital edema
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
13.6%
3/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
9.1%
2/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
81.8%
18/22 • Number of events 46 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.9%
9/22 • Number of events 19 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
4/22 • Number of events 9 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
27.3%
6/22 • Number of events 7 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
40.9%
9/22 • Number of events 13 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
27.3%
6/22 • Number of events 10 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
27.3%
6/22 • Number of events 15 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
31.8%
7/22 • Number of events 13 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
45.5%
10/22 • Number of events 19 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Nail infection
|
9.1%
2/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
3/22 • Number of events 9 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.6%
3/22 • Number of events 5 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
31.8%
7/22 • Number of events 18 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders - other, specify: cercarial dermatitis/swimmer's itch
|
4.5%
1/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders - other, specify: Abrasion
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders - other, specify: bug bite
|
13.6%
3/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders - other, specify: erythema
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders - other, specify: Laceration
|
13.6%
3/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other, specify: Skin sensitivity
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders - other, specify: Wound
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Surgical and medical procedures
Surgical procedure - other, specify: Biopsy /wart removal
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Surgical and medical procedures
Surgical procedure - other, specify: biopsy, face, head, back
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Surgical and medical procedures
Surgical procedure - other, specify: pre-cancerous areas removed
|
9.1%
2/22 • Number of events 3 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Surgical and medical procedures
Surgical procedure - other, specify: shaved excision of dysplastic nevus
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Vascular disorders
Arterial injury
|
4.5%
1/22 • Number of events 2 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Vascular disorders
Hot flashes
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Vascular disorders
Hypertension
|
13.6%
3/22 • Number of events 4 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months.
Adverse events were assessed at every study treatment visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place