Trial Outcomes & Findings for Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma (NCT NCT01118026)
NCT ID: NCT01118026
Last Updated: 2021-12-01
Results Overview
Progression-free survival (PFS) is defined as the time from first PET/CT scan to disease progression or death. Patients who are alive without disease progression will be censored at the time of their most recent disease evaluation. The Kaplan-Meier three-year (36 month) survival estimates and confidence intervals are presented below.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2021-12-01
Participant Flow
Participant milestones
| Measure |
ABVD +/- BEACOPP + Radiation
Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. \> \> Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). \>
\> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).\>
\> All patients will be followed for a maximum of ten years.\>
\> ABVD: doxorubicin 25 mg/m\^2 IV\> bleomycin 10 units/m\^2 IV\> vinblastine 6 mg/m\^2 IV\> dacarbazine 375 mg/m\^2 IV\>
\> BEACOPP: bleomycin 10 units/m\^2 IV on Day 8\> etoposide 200 mg/m\^2 IV on Days 1, 2 and 3\> doxorubicin 35 mg/m\^2 IV on Day 1\> cyclophosphamide 1250 mg/m\^2 IV on Day 1\> vincristine 1.4 mg/m\^2 IV on Day 8\> procarbazine 100 mg/m\^2 orally on Days 1-7\> prednisone 40 mg/m\^2 orally on Days 1-14\>
\> radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
ABVD +/- BEACOPP + Radiation
n=94 Participants
Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. \> \> Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). \>
\> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).\>
\> All patients will be followed for a maximum of ten years.\>
\> ABVD: doxorubicin 25 mg/m\^2 IV\> bleomycin 10 units/m\^2 IV\> vinblastine 6 mg/m\^2 IV\> dacarbazine 375 mg/m\^2 IV\>
\> BEACOPP: bleomycin 10 units/m\^2 IV on Day 8\> etoposide 200 mg/m\^2 IV on Days 1, 2 and 3\> doxorubicin 35 mg/m\^2 IV on Day 1\> cyclophosphamide 1250 mg/m\^2 IV on Day 1\> vincristine 1.4 mg/m\^2 IV on Day 8\> procarbazine 100 mg/m\^2 orally on Days 1-7\> prednisone 40 mg/m\^2 orally on Days 1-14\>
\> radiation therapy
|
|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Six patients were not eligible for this analysis and one patient was not evaluated for PET status screening. All patients that were eligible and evaluated for PET screening were included in this analysis.
Progression-free survival (PFS) is defined as the time from first PET/CT scan to disease progression or death. Patients who are alive without disease progression will be censored at the time of their most recent disease evaluation. The Kaplan-Meier three-year (36 month) survival estimates and confidence intervals are presented below.
Outcome measures
| Measure |
ABVD (PET-negative)
n=73 Participants
Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. \> \> Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). \>
\>
\> All patients will be followed for a maximum of ten years.\>
\> ABVD: doxorubicin 25 mg/m\^2 IV\> bleomycin 10 units/m\^2 IV\> vinblastine 6 mg/m\^2 IV\> dacarbazine 375 mg/m\^2 IV
|
ABVD + BEACOPP + Radiation (PET-positive)
n=21 Participants
Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. \> \> Patients undergo a PET scan following two cycles of ABVD. If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). \>
\> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).\>
\> All patients will be followed for a maximum of ten years.\>
\> ABVD: doxorubicin 25 mg/m\^2 IV\> bleomycin 10 units/m\^2 IV\> vinblastine 6 mg/m\^2 IV\> dacarbazine 375 mg/m\^2 IV\>
\> BEACOPP: bleomycin 10 units/m\^2 IV on Day 8\> etoposide 200 mg/m\^2 IV on Days 1, 2 and 3\> doxorubicin 35 mg/m\^2 IV on Day 1\> cyclophosphamide 1250 mg/m\^2 IV on Day 1\> vincristine 1.4 mg/m\^2 IV on Day 8\> procarbazine 100 mg/m\^2 orally on Days 1-7\> prednisone 40 mg/m\^2 orally on Days 1-14\>
\> radiation therapy
|
|---|---|---|
|
Progression-free Survival at 36 Months
|
93.1 percentage of participants
Interval 87.4 to 99.1
|
89.7 percentage of participants
Interval 77.2 to 100.0
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All eligible patients patients who were screened for PET status and were evaluated for response are included in this analysis.
A Complete Response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. For this endpoint, the best response at any time post-baseline was analyzed
Outcome measures
| Measure |
ABVD (PET-negative)
n=73 Participants
Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. \> \> Patients undergo a PET scan following two cycles of ABVD. If the PET scan is negative, then the patient will receive four more cycles of ABVD (a total of 6 cycles of ABVD). \>
\>
\> All patients will be followed for a maximum of ten years.\>
\> ABVD: doxorubicin 25 mg/m\^2 IV\> bleomycin 10 units/m\^2 IV\> vinblastine 6 mg/m\^2 IV\> dacarbazine 375 mg/m\^2 IV
|
ABVD + BEACOPP + Radiation (PET-positive)
n=21 Participants
Patients receive ABVD administered by intravenous (IV) infusion on days 1 and 15 of each cycle. A cycle is considered 28 days. Patients receive a total of two cycles. \> \> Patients undergo a PET scan following two cycles of ABVD. If the PET scan is positive, then the patient receives four cycles of escalated BEACOPP for 21 days (a total of 4 cycles). \>
\> 3-6 weeks after BEACOPP therapy, patients receive radiation therapy for 5 days per week (a total of 3.5 weeks).\>
\> All patients will be followed for a maximum of ten years.\>
\> ABVD: doxorubicin 25 mg/m\^2 IV\> bleomycin 10 units/m\^2 IV\> vinblastine 6 mg/m\^2 IV\> dacarbazine 375 mg/m\^2 IV\>
\> BEACOPP: bleomycin 10 units/m\^2 IV on Day 8\> etoposide 200 mg/m\^2 IV on Days 1, 2 and 3\> doxorubicin 35 mg/m\^2 IV on Day 1\> cyclophosphamide 1250 mg/m\^2 IV on Day 1\> vincristine 1.4 mg/m\^2 IV on Day 8\> procarbazine 100 mg/m\^2 orally on Days 1-7\> prednisone 40 mg/m\^2 orally on Days 1-14\>
\> radiation therapy
|
|---|---|---|
|
Complete Response
|
73 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
Adverse Events
ABVD +/- BEACOPP + Radiation
Serious events: 0 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABVD +/- BEACOPP + Radiation
n=100 participants at risk
radiation therapy
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
75/100 • Number of events 300 • Up to 36 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.0%
9/100 • Number of events 11 • Up to 36 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Cardiac disorders
Sinus tachycardia
|
7.0%
7/100 • Number of events 12 • Up to 36 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Ear and labyrinth disorders
Ear pain
|
3.0%
3/100 • Number of events 3 • Up to 36 months
|
|
Endocrine disorders
Cushingoid
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Eye disorders
Blurred vision
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Eye disorders
Dry eye
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Eye disorders
Flashing lights
|
1.0%
1/100 • Number of events 3 • Up to 36 months
|
|
Eye disorders
Watering eyes
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Abdominal pain
|
17.0%
17/100 • Number of events 19 • Up to 36 months
|
|
Gastrointestinal disorders
Bloating
|
6.0%
6/100 • Number of events 12 • Up to 36 months
|
|
Gastrointestinal disorders
Cheilitis
|
1.0%
1/100 • Number of events 4 • Up to 36 months
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
49.0%
49/100 • Number of events 117 • Up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
27.0%
27/100 • Number of events 45 • Up to 36 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
6/100 • Number of events 16 • Up to 36 months
|
|
Gastrointestinal disorders
Dyspepsia
|
17.0%
17/100 • Number of events 31 • Up to 36 months
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
10/100 • Number of events 12 • Up to 36 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Esophageal pain
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
3/100 • Number of events 5 • Up to 36 months
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.0%
8/100 • Number of events 12 • Up to 36 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
4.0%
4/100 • Number of events 4 • Up to 36 months
|
|
Gastrointestinal disorders
Gingival pain
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.0%
4/100 • Number of events 8 • Up to 36 months
|
|
Gastrointestinal disorders
Mucositis oral
|
36.0%
36/100 • Number of events 61 • Up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
83.0%
83/100 • Number of events 275 • Up to 36 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Gastrointestinal disorders
Oral pain
|
13.0%
13/100 • Number of events 15 • Up to 36 months
|
|
Gastrointestinal disorders
Periodontal disease
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Proctitis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Rectal pain
|
3.0%
3/100 • Number of events 7 • Up to 36 months
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
5/100 • Number of events 10 • Up to 36 months
|
|
Gastrointestinal disorders
Toothache
|
3.0%
3/100 • Number of events 5 • Up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
33.0%
33/100 • Number of events 61 • Up to 36 months
|
|
General disorders
Chills
|
9.0%
9/100 • Number of events 12 • Up to 36 months
|
|
General disorders
Edema face
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
General disorders
Edema limbs
|
9.0%
9/100 • Number of events 19 • Up to 36 months
|
|
General disorders
Edema trunk
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
General disorders
Facial pain
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
General disorders
Fatigue
|
80.0%
80/100 • Number of events 279 • Up to 36 months
|
|
General disorders
Fever
|
19.0%
19/100 • Number of events 29 • Up to 36 months
|
|
General disorders
Flu like symptoms
|
3.0%
3/100 • Number of events 4 • Up to 36 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
7.0%
7/100 • Number of events 11 • Up to 36 months
|
|
General disorders
Injection site reaction
|
6.0%
6/100 • Number of events 8 • Up to 36 months
|
|
General disorders
Localized edema
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
General disorders
Malaise
|
4.0%
4/100 • Number of events 7 • Up to 36 months
|
|
General disorders
Non-cardiac chest pain
|
18.0%
18/100 • Number of events 27 • Up to 36 months
|
|
General disorders
Pain
|
13.0%
13/100 • Number of events 20 • Up to 36 months
|
|
Immune system disorders
Cytokine release syndrome
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Anorectal infection
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Bronchial infection
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Conjunctivitis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
9.0%
9/100 • Number of events 9 • Up to 36 months
|
|
Infections and infestations
Lung infection
|
3.0%
3/100 • Number of events 3 • Up to 36 months
|
|
Infections and infestations
Mucosal infection
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Nail infection
|
5.0%
5/100 • Number of events 5 • Up to 36 months
|
|
Infections and infestations
Otitis media
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Infections and infestations
Papulopustular rash
|
1.0%
1/100 • Number of events 3 • Up to 36 months
|
|
Infections and infestations
Paronychia
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Infections and infestations
Sepsis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Sinusitis
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Skin infection
|
6.0%
6/100 • Number of events 7 • Up to 36 months
|
|
Infections and infestations
Tooth infection
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Upper respiratory infection
|
11.0%
11/100 • Number of events 17 • Up to 36 months
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Infections and infestations
Vaginal infection
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Bruising
|
3.0%
3/100 • Number of events 7 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
5.0%
5/100 • Number of events 5 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.0%
5/100 • Number of events 7 • Up to 36 months
|
|
Investigations
Alanine aminotransferase increased
|
34.0%
34/100 • Number of events 66 • Up to 36 months
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
12/100 • Number of events 13 • Up to 36 months
|
|
Investigations
Aspartate aminotransferase increased
|
23.0%
23/100 • Number of events 35 • Up to 36 months
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Investigations
CD4 lymphocytes decreased
|
3.0%
3/100 • Number of events 8 • Up to 36 months
|
|
Investigations
CO diffusing capacity decreased
|
4.0%
4/100 • Number of events 9 • Up to 36 months
|
|
Investigations
Cholesterol high
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Investigations
Creatinine increased
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Investigations
Forced expiratory volume decreased
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Investigations
Hemoglobin increased
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Investigations
INR increased
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Investigations
Investigations - Other, specify
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Investigations
Lymphocyte count decreased
|
54.0%
54/100 • Number of events 228 • Up to 36 months
|
|
Investigations
Lymphocyte count increased
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Investigations
Neutrophil count decreased
|
94.0%
94/100 • Number of events 468 • Up to 36 months
|
|
Investigations
Platelet count decreased
|
21.0%
21/100 • Number of events 56 • Up to 36 months
|
|
Investigations
Vital capacity abnormal
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Investigations
Weight gain
|
8.0%
8/100 • Number of events 20 • Up to 36 months
|
|
Investigations
Weight loss
|
4.0%
4/100 • Number of events 12 • Up to 36 months
|
|
Investigations
White blood cell decreased
|
93.0%
93/100 • Number of events 459 • Up to 36 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
25/100 • Number of events 47 • Up to 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
2/100 • Number of events 5 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.0%
28/100 • Number of events 63 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.0%
15/100 • Number of events 35 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.0%
15/100 • Number of events 25 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.0%
3/100 • Number of events 5 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.0%
17/100 • Number of events 33 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.0%
9/100 • Number of events 10 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.0%
18/100 • Number of events 35 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.0%
17/100 • Number of events 32 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
10/100 • Number of events 12 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
2/100 • Number of events 5 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
2/100 • Number of events 5 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.0%
1/100 • Number of events 5 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
3.0%
3/100 • Number of events 7 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
20/100 • Number of events 39 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.0%
4/100 • Number of events 5 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.0%
16/100 • Number of events 30 • Up to 36 months
|
|
Nervous system disorders
Akathisia
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Nervous system disorders
Amnesia
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Nervous system disorders
Cognitive disturbance
|
2.0%
2/100 • Number of events 6 • Up to 36 months
|
|
Nervous system disorders
Concentration impairment
|
1.0%
1/100 • Number of events 4 • Up to 36 months
|
|
Nervous system disorders
Dizziness
|
15.0%
15/100 • Number of events 25 • Up to 36 months
|
|
Nervous system disorders
Dysesthesia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Dysgeusia
|
11.0%
11/100 • Number of events 31 • Up to 36 months
|
|
Nervous system disorders
Headache
|
30.0%
30/100 • Number of events 62 • Up to 36 months
|
|
Nervous system disorders
Memory impairment
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
3.0%
3/100 • Number of events 4 • Up to 36 months
|
|
Nervous system disorders
Neuralgia
|
3.0%
3/100 • Number of events 3 • Up to 36 months
|
|
Nervous system disorders
Paresthesia
|
6.0%
6/100 • Number of events 12 • Up to 36 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.0%
9/100 • Number of events 23 • Up to 36 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.0%
42/100 • Number of events 103 • Up to 36 months
|
|
Nervous system disorders
Seizure
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
Anxiety
|
19.0%
19/100 • Number of events 55 • Up to 36 months
|
|
Psychiatric disorders
Depression
|
5.0%
5/100 • Number of events 9 • Up to 36 months
|
|
Psychiatric disorders
Insomnia
|
22.0%
22/100 • Number of events 64 • Up to 36 months
|
|
Psychiatric disorders
Irritability
|
1.0%
1/100 • Number of events 5 • Up to 36 months
|
|
Psychiatric disorders
Libido decreased
|
2.0%
2/100 • Number of events 5 • Up to 36 months
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Renal and urinary disorders
Renal hemorrhage
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Renal and urinary disorders
Urinary frequency
|
6.0%
6/100 • Number of events 12 • Up to 36 months
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Renal and urinary disorders
Urinary urgency
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Reproductive system and breast disorders
Penile pain
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.0%
4/100 • Number of events 4 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
60/100 • Number of events 125 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
50/100 • Number of events 115 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.0%
1/100 • Number of events 3 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.0%
18/100 • Number of events 23 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
3/100 • Number of events 7 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
5/100 • Number of events 8 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
6.0%
6/100 • Number of events 7 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.0%
2/100 • Number of events 3 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.0%
12/100 • Number of events 16 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.0%
38/100 • Number of events 109 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Body odor
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.0%
1/100 • Number of events 3 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
4/100 • Number of events 9 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.0%
3/100 • Number of events 3 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.0%
3/100 • Number of events 10 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.0%
2/100 • Number of events 7 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
2.0%
2/100 • Number of events 4 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.0%
4/100 • Number of events 6 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.0%
18/100 • Number of events 29 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
5/100 • Number of events 14 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.0%
12/100 • Number of events 23 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.0%
2/100 • Number of events 7 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
12.0%
12/100 • Number of events 19 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.0%
9/100 • Number of events 19 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/100 • Number of events 2 • Up to 36 months
|
|
Vascular disorders
Flushing
|
2.0%
2/100 • Number of events 2 • Up to 36 months
|
|
Vascular disorders
Hematoma
|
1.0%
1/100 • Number of events 1 • Up to 36 months
|
|
Vascular disorders
Hot flashes
|
7.0%
7/100 • Number of events 14 • Up to 36 months
|
|
Vascular disorders
Hypertension
|
11.0%
11/100 • Number of events 37 • Up to 36 months
|
|
Vascular disorders
Hypotension
|
4.0%
4/100 • Number of events 5 • Up to 36 months
|
|
Vascular disorders
Phlebitis
|
6.0%
6/100 • Number of events 13 • Up to 36 months
|
|
Vascular disorders
Superficial thrombophlebitis
|
5.0%
5/100 • Number of events 10 • Up to 36 months
|
|
Vascular disorders
Thromboembolic event
|
5.0%
5/100 • Number of events 11 • Up to 36 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.0%
2/100 • Number of events 6 • Up to 36 months
|
Additional Information
Ann S. LaCasce, MD
Alliance for Clinical Trials in Oncology
Phone: 617-632-5959
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60