Trial Outcomes & Findings for Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma (NCT NCT00720876)
NCT ID: NCT00720876
Last Updated: 2018-08-07
Results Overview
Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), \>=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
After every 3 cycles, up to 1 year after the start of treatment
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
Vorinostat and Rituximab
Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Vorinostat and Rituximab
Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Overall Study
found to be ineligible after starting tx
|
2
|
Baseline Characteristics
Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Vorinostat and Rituximab
n=28 Participants
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After every 3 cycles, up to 1 year after the start of treatmentResponse was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), \>=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Vorinostat and Rituximab
n=28 Participants
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Overall Response Rate (Complete and Partial Response)
|
46 percentage of participants
|
SECONDARY outcome
Timeframe: Until disease progress\relapse, up to 1 year after the start of treatmentProgression\\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis. Estimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Vorinostat and Rituximab
n=28 Participants
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Progression-free Survival
|
29.2 Months
Interval 14.4 to 51.0
|
SECONDARY outcome
Timeframe: 3 weeks after the stop of treatmentGrade 3 \& 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.
Outcome measures
| Measure |
Vorinostat and Rituximab
n=28 Participants
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Number of Participants With Grade 3 and 4 Toxicities
Neutrophil count decreased
|
3 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Platelet count decreased
|
5 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Hemoglobin decreased
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Lymphocyte count decreased
|
7 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Hypotension
|
2 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Chills
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Fatigue
|
9 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Dehydration
|
3 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Diarrhea
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Kidney infection
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Pneumonia
|
2 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Sepsis
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Urinary tract infection
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Localized edema
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Alanine aminotransferase increased
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Aspartate aminotransferase increased
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Blood glucose increased
|
3 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Serum phosphate decreased
|
3 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Serum potassium decreased
|
2 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Muscle weakness
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Syncope
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Hypoxia
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Pneumonitis
|
1 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Thrombosis
|
4 Participants
|
|
Number of Participants With Grade 3 and 4 Toxicities
Vascular access complication
|
1 Participants
|
Adverse Events
Vorinostat and Rituximab
Serious events: 13 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat and Rituximab
n=30 participants at risk
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Kidney infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thrombosis
|
13.3%
4/30 • Number of events 5 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Vorinostat and Rituximab
n=30 participants at risk
Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks .
rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
73.3%
22/30 • Number of events 152 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.3%
1/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 8 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorder
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
6.7%
2/30 • Number of events 5 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
External ear pain
|
3.3%
1/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
13.3%
4/30 • Number of events 6 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
6.7%
2/30 • Number of events 8 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
6/30 • Number of events 13 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
43.3%
13/30 • Number of events 48 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
53.3%
16/30 • Number of events 50 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
24/30 • Number of events 304 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
36.7%
11/30 • Number of events 27 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
26.7%
8/30 • Number of events 19 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
3/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
10/30 • Number of events 14 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.7%
2/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
73.3%
22/30 • Number of events 174 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.3%
1/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
2/30 • Number of events 12 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
2/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Toothache
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
10/30 • Number of events 33 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
26.7%
8/30 • Number of events 9 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
53.3%
16/30 • Number of events 67 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
36.7%
11/30 • Number of events 26 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Facial pain
|
6.7%
2/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
86.7%
26/30 • Number of events 279 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
46.7%
14/30 • Number of events 26 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu-like symptoms
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
13.3%
4/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
13.3%
4/30 • Number of events 14 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
20.0%
6/30 • Number of events 8 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Hypersensitivity
|
26.7%
8/30 • Number of events 10 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Eye infection
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Lip infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Nail infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Peripheral nerve infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Pneumonia
|
13.3%
4/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Rhinitis infective
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
16.7%
5/30 • Number of events 17 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Tooth infection
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
26.7%
8/30 • Number of events 9 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
6/30 • Number of events 12 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Wound infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
10/30 • Number of events 13 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.3%
1/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
6/30 • Number of events 13 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
36.7%
11/30 • Number of events 20 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
10/30 • Number of events 37 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
18/30 • Number of events 54 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
3.3%
1/30 • Number of events 9 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
60.0%
18/30 • Number of events 128 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
53.3%
16/30 • Number of events 143 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
36.7%
11/30 • Number of events 49 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
50.0%
15/30 • Number of events 75 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
66.7%
20/30 • Number of events 137 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
10.0%
3/30 • Number of events 7 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
63.3%
19/30 • Number of events 71 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
6.7%
2/30 • Number of events 8 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
50.0%
15/30 • Number of events 55 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
6/30 • Number of events 9 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
50.0%
15/30 • Number of events 45 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
53.3%
16/30 • Number of events 51 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
10.0%
3/30 • Number of events 11 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
53.3%
16/30 • Number of events 90 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
16.7%
5/30 • Number of events 10 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
30.0%
9/30 • Number of events 16 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
13.3%
4/30 • Number of events 14 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
30.0%
9/30 • Number of events 22 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
50.0%
15/30 • Number of events 63 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.7%
2/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
8/30 • Number of events 17 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
3/30 • Number of events 17 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
5/30 • Number of events 5 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
26.7%
8/30 • Number of events 17 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
40.0%
12/30 • Number of events 16 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
13.3%
4/30 • Number of events 6 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
6.7%
2/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
10.0%
3/30 • Number of events 9 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
6/30 • Number of events 11 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
3/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
36.7%
11/30 • Number of events 66 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
40.0%
12/30 • Number of events 41 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
46.7%
14/30 • Number of events 58 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
13.3%
4/30 • Number of events 8 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuralgia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
2/30 • Number of events 7 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.3%
7/30 • Number of events 14 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Speech disorder
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
33.3%
10/30 • Number of events 47 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
10.0%
3/30 • Number of events 9 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Agitation
|
10.0%
3/30 • Number of events 7 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
16.7%
5/30 • Number of events 24 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
16.7%
5/30 • Number of events 8 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
30.0%
9/30 • Number of events 28 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Psychosis
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
6.7%
2/30 • Number of events 5 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
3.3%
1/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urethral pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • Number of events 7 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urogenital disorder
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
40.0%
12/30 • Number of events 23 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
10.0%
3/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
15/30 • Number of events 106 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
12/30 • Number of events 59 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
13.3%
4/30 • Number of events 7 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
30.0%
9/30 • Number of events 19 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
3/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
10/30 • Number of events 64 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
5/30 • Number of events 6 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.7%
2/30 • Number of events 17 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
23.3%
7/30 • Number of events 15 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
30.0%
9/30 • Number of events 13 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
6.7%
2/30 • Number of events 2 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
6.7%
2/30 • Number of events 3 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
26.7%
8/30 • Number of events 25 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
13.3%
4/30 • Number of events 4 • Adverse events were collected over a period of seven years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place