Trial Outcomes & Findings for Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma (NCT NCT01995669)
NCT ID: NCT01995669
Last Updated: 2025-06-24
Results Overview
To determine the maximum tolerated dose of lenalidomide plus obinutuzumab in relapsed/refractory indolent lymphoma the 3 by 3 method was used. (Phase I) Doses of Lenalidomide to be used are 10mg, 15mg, 20mg in Phase 1.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
28 days after 168 days (6 courses)
Results posted on
2025-06-24
Participant Flow
Patients were enrolled into an investigator initiated, open-label, phase 1/2 trial at a single institution, MD Anderson Cancer Center, Houston, TX, US.
Participant milestones
| Measure |
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase II: Expansion Len 20 mg Plus Obin 1000 mg
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
57
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
29
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase II: Expansion Len 20 mg Plus Obin 1000 mg
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma
|
|---|---|---|---|---|
|
Overall Study
Progression
|
2
|
1
|
1
|
13
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
|
Overall Study
Insurance Expired
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab
n=3 Participants
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab
n=3 Participants
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
n=3 Participants
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Ph. II: Expansion Len 20 mg Plus Obin 1000 mg
n=57 Participants
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 days after 168 days (6 courses)Population: Phase II was not assessed.
To determine the maximum tolerated dose of lenalidomide plus obinutuzumab in relapsed/refractory indolent lymphoma the 3 by 3 method was used. (Phase I) Doses of Lenalidomide to be used are 10mg, 15mg, 20mg in Phase 1.
Outcome measures
| Measure |
All Participants
n=9 Participants
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
|
|---|---|
|
Maximum Tolerated Dose of Lenalidomide When Given With Obinutuzumab Defined as the Highest Dose Level Have Been Treated With Less Than 2 Instances of Dose Limiting Toxicity DLT.
|
20 mg
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Phase I was not assessed for this outcome.
The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
Outcome measures
| Measure |
All Participants
n=57 Participants
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
|
|---|---|
|
Overall Survival, Time to Progression, and Progression Free Survival (Phase II)
PFS
|
44.2 months
Interval 22.5 to
Median PFS was not reached due to insufficient number of patients with events.
|
|
Overall Survival, Time to Progression, and Progression Free Survival (Phase II)
OS
|
NA months
Median OS was not reached due to insufficient number of patients with events.
|
|
Overall Survival, Time to Progression, and Progression Free Survival (Phase II)
TTP
|
44.2 months
Interval 26.6 to
Median TTP was not reached due to insufficient number of patients with events.
|
Adverse Events
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ph. II: Expansion Len 20 mg Plus Obin 1000 mg
Serious events: 34 serious events
Other events: 57 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab
n=3 participants at risk
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab
n=3 participants at risk
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
n=3 participants at risk
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Ph. II: Expansion Len 20 mg Plus Obin 1000 mg
n=57 participants at risk
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma
|
|---|---|---|---|---|
|
Infections and infestations
Lung Infection
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
8.8%
5/57 • Number of events 8 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
100.0%
3/3 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Reproductive system and breast disorders
Unintented Pregnancy
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Gastroeophogeal reflux disease
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Tumor Lysis Syndrome
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Chest pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Sinus Tackycardia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Syncope
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Fever
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Heart Faliure
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Pacemaker implant
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Bactermia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Cellulitis - left Mandible
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Cellulitis - right calf
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Infection - JC Virus
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Infection, pacemaker infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Nervous system disorders
Vertigo
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Gallbladder obstruction
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorder - testicular pain and dysuria
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
Other adverse events
| Measure |
Phase I Dose Level 10mg Lenolidomide + 1000mg Obinutuzimab
n=3 participants at risk
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 15mg Lenolidomide + 1000mg Obinutuzimab
n=3 participants at risk
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Phase I Dose Level 20mg Lenolidomide + 1000mg Obinutuzimab
n=3 participants at risk
Patients with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma
|
Ph. II: Expansion Len 20 mg Plus Obin 1000 mg
n=57 participants at risk
Participants with relapsed or refractory WHO Grade 1 to 3A follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
10.5%
6/57 • Number of events 6 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Allergic reaction
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
14.0%
8/57 • Number of events 8 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
19.3%
11/57 • Number of events 12 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Anxiety
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Appetite Change, Increase
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
24.6%
14/57 • Number of events 19 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Blurred Vision
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
21.1%
12/57 • Number of events 13 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Cataract
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Chills
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
8.8%
5/57 • Number of events 5 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Confusion
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Conjunctivitis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 6 • from consent up to 30 days post last dose, up to 4 years
|
43.9%
25/57 • Number of events 44 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
57.9%
33/57 • Number of events 48 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Creatinine increased
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Deconditioning
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Decreased Visual Acuity
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Depression
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 9 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 7 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 7 • from consent up to 30 days post last dose, up to 4 years
|
40.4%
23/57 • Number of events 55 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Dizziness
|
100.0%
3/3 • Number of events 5 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
19/57 • Number of events 29 • from consent up to 30 days post last dose, up to 4 years
|
|
Eye disorders
Dry Eye
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
26.3%
15/57 • Number of events 19 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
100.0%
3/3 • Number of events 4 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 10 • from consent up to 30 days post last dose, up to 4 years
|
31.6%
18/57 • Number of events 27 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Edema - Face
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
10.5%
6/57 • Number of events 10 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Edema - Limbs
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
38.6%
22/57 • Number of events 30 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Edema - Trunk
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
7.0%
4/57 • Number of events 5 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Eye disorders - Double Vision
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Eye disorders -Watery eye (1 #9)
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Eye Infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Eye Stye
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Fall
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 21 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 13 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 8 • from consent up to 30 days post last dose, up to 4 years
|
87.7%
50/57 • Number of events 112 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
28.1%
16/57 • Number of events 26 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Floaters
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Flu-like symptoms
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Flushing
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Gallbladder obstruction
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Glaucoma
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Headache
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
14.0%
8/57 • Number of events 11 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Hepatic enzyme elevation
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Hypogammaglobulinemia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Hypomagnesmia
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Infections and infestations - Pneumonia
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Investigations Other - Elevated LDH
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
8.8%
5/57 • Number of events 8 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Memory Impairment
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 4 • from consent up to 30 days post last dose, up to 4 years
|
19.3%
11/57 • Number of events 16 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
19.3%
11/57 • Number of events 15 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 12 • from consent up to 30 days post last dose, up to 4 years
|
43.9%
25/57 • Number of events 49 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 5 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
35.1%
20/57 • Number of events 30 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
26.3%
15/57 • Number of events 33 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Pacemaker Placed
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
28.1%
16/57 • Number of events 20 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
19.3%
11/57 • Number of events 21 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 4 • from consent up to 30 days post last dose, up to 4 years
|
14.0%
8/57 • Number of events 9 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
61.4%
35/57 • Number of events 60 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Chest congestion
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Upper Respiratory Infection
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
19.3%
11/57 • Number of events 12 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Sinus infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
17.5%
10/57 • Number of events 13 • from consent up to 30 days post last dose, up to 4 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Cardiac disorders
Syncope
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Tinnitus
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
66.7%
2/3 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Nervous system disorders
Twitching
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Reproductive system and breast disorders
Unintended Pregnancy
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
14.0%
8/57 • Number of events 10 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/57 • from consent up to 30 days post last dose, up to 4 years
|
|
Blood and lymphatic system disorders
White Blood Cell Decreased
|
33.3%
1/3 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 4 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Hearing Impaired
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Hot flashes
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Hypersensitive smell
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Influenza
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Insomnia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Localized edema
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Paresthesia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Sleep disturbance
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Swollen eye
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Toothache
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Visual disturbance
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Watering eyes
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Weight gain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Weight loss
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
General disorders
Migraine
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Facial Cellulitis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Mycobacterial Avium infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Nasal congestion
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
15.8%
9/57 • Number of events 10 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Epididymoorchitis with possible abscess
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Scratchy throat-closing
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Shingles
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Infections and infestations
Staph infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
7.0%
4/57 • Number of events 8 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
10.5%
6/57 • Number of events 7 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
7.0%
4/57 • Number of events 4 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Testicular pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Right toe strain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Difficulty Urinating
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
3.5%
2/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
5.3%
3/57 • Number of events 3 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Vaginal discharge
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Renal and urinary disorders
Renal cell carcinoma
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Insect bite
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 2 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 4 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Wasp bite
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Abcess
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Color change on abdomen
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Plantar's wart
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
|
Skin and subcutaneous tissue disorders
Plaque psoriasis
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
0.00%
0/3 • from consent up to 30 days post last dose, up to 4 years
|
1.8%
1/57 • Number of events 1 • from consent up to 30 days post last dose, up to 4 years
|
Additional Information
Dr. Loretta Nastoupil
University of Texas M D Anderson Cancer Center
Phone: (713) 792-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place