Trial Outcomes & Findings for Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma (NCT NCT00808639)
NCT ID: NCT00808639
Last Updated: 2016-10-24
Results Overview
Pathological response is defined as down-staging to \</=pT1, N0 after chemotherapy with pegfilgrastim support.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Dose Dense MVAC
Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dose Dense MVAC
Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
|
|---|---|
|
Overall Study
Disease progression before surgery.
|
1
|
Baseline Characteristics
Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Dose Dense MVAC
n=39 Participants
Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
39 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
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)Population: Analysis population consists of all enrolled patients.
Pathological response is defined as down-staging to \</=pT1, N0 after chemotherapy with pegfilgrastim support.
Outcome measures
| Measure |
Dose Dense MVAC
n=39 Participants
Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose
|
|---|---|
|
Number of Patients Achieving Pathologic Response
|
49 percentage of pathologic responders
Interval 35.0 to 63.0
|
SECONDARY outcome
Timeframe: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.
Outcome measures
| Measure |
Dose Dense MVAC
n=39 Participants
Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose
|
|---|---|
|
Number of Patients Experiencing Febrile Neutropenia
|
0 participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Surgery + 30 daysPopulation: Number of patients who underwent cystectomy.
Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.
Outcome measures
| Measure |
Dose Dense MVAC
n=38 Participants
Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose
|
|---|---|
|
Number of Patients Experiencing Surgery-related Toxicity
|
4 participants
Interval 4.0 to 22.0
|
Adverse Events
Dose Dense MVAC
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Dense MVAC
n=39 participants at risk
Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose
|
|---|---|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
Other adverse events
| Measure |
Dose Dense MVAC
n=39 participants at risk
Methotrexate: intravenously 30mg/m2 over 30 minutes
Doxorubicin: intravenously 30mg/ms over 15 minutes
vinblastine: intravenously 3mg/m2 over 30 minutes
cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
3/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Opportunistic infection lymphopenia>=gr1
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Vascular disorders
Phlebitis
|
5.1%
2/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.1%
2/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Chelitis
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
9/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
2/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
3/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
10.3%
4/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
23.1%
9/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
15/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
4/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
GI-other
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Fatigue
|
69.2%
27/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Edema limb
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Pain-other
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection Gr0-2 neut, mucosa
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Leukocytes
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Weight loss
|
5.1%
2/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Coagulation-other
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
ALT, SGPT
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.5%
8/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
3/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Taste disturbance
|
17.9%
7/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Dizziness
|
7.7%
3/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Neuropathy CN I smell
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Neuropathy-sensory
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Head/headache
|
12.8%
5/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis (symptom) trachea
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
7.7%
3/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.6%
1/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
5.1%
2/39 • Reported adverse events include events starting on or after day 0 through 30 days post treatment.
Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place