Trial Outcomes & Findings for A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer (NCT NCT01671488)
NCT ID: NCT01671488
Last Updated: 2020-02-17
Results Overview
Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Treatment
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer
Baseline characteristics by cohort
| Measure |
Treatment
n=11 Participants
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
60.36 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.Population: Patient's who received treatment on study
Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.
Outcome measures
| Measure |
Treatment
n=10 Participants
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.
|
10 Participants
|
PRIMARY outcome
Timeframe: Tumor evaluation 6 months after coming off studyPopulation: Number of patient's who received treatment on study
Patients to undergo tumor evaluation assessment (via sigmoidoscopy, proctoscopy, colonoscopy or anoscope) 6 months post the start of chemotherapy/radiation.
Outcome measures
| Measure |
Treatment
n=10 Participants
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.
|
9 Participants
|
SECONDARY outcome
Timeframe: Follow up and survival status at 6 months and 1 year post coming off study and annually until patient has been off for 5 yearsPopulation: As one patient expired prior to 6 month assessment, the total n used was 9 to assess PFS
Patients terminating study treatment early prior to disease recurrence will be followed every 6 months for year 1 then annually for a total of 5 years. The follow-up portion will commence once patient comes off study or post the 2-6 week post the 4th treatment time point/visit. Assessments were tumor evaluation via sigmoidoscopy, proctoscopy, colonoscopy or anoscope and also chest/abdomen/pelvic imaging.
Outcome measures
| Measure |
Treatment
n=9 Participants
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.
|
8 Participants
|
Adverse Events
Treatment
Serious events: 10 serious events
Other events: 8 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Treatment
n=10 participants at risk
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
Investigations
fever (1), hypotension(2)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
fever (1), hypotension(2) Hypokalemia (3)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
weakness (3), decreased appetite (2), GI bleed(3). Anemia(3)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Nausea (3), dehydration (3), anal mucositis (3), enterocolitis (2)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Nausea(3),dehydration(3),anal mucositis(3),
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Expired unknown reason (5)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
seizure (3), catastrophic pulmonary or cardiac event or massive CVA (5)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
PLT(4), diarrhea (2), ANC (3), fever (1)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Diarrhea (3), dehydration(3), wt loss (2), back pain (2), fatigue (2),
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Diarrhea (2), wt loss (2) , back pain (1), fatigue (2),
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
fever (1) headache (1)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Fever(1*)febrile neutropenia(3*)ANC(3*)WBC (4*), PLT (4*)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
ANC (4*)WBC(4*)PLT(3*)Anemia (3*)cellulitis (2*),mucositis (1*)Lymph (4*),
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
chest pain (1*), shortness of breath (3*), lightheadedness (1*)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Rectal bleeding (3*), Anemia (2*) , ANC(3*) , PLT(4*) , Fever (1*)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Rectal bleeding (3*)Anemia (3*)ANC(4*)PLT(4*)Fever (1*)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
Other adverse events
| Measure |
Treatment
n=10 participants at risk
The first dose will be given 10-14 days prior to the initiation of chemoradiation.
Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.
The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.
Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction.
|
|---|---|
|
Investigations
allergies
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
ALT
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
anal mucositis
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
ANC
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Anemia
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
anorexia
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
anxiety
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
APTT
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
AST
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
chills/rigors
|
80.0%
8/10 • Number of events 8 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
constipation
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
confusion
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
creatinine
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Dehydration
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
depression
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Diarrhea
|
50.0%
5/10 • Number of events 5 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Frequent stools (non-diarrhea)
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
fecal incontinence
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Dizziness
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
dyspepsia
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Dyspnea/SOB
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
edema
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
erythoderma/erythema
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
dry skin
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
ejaculatory dysfunction
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
epistaxis
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Fatigue
|
60.0%
6/10 • Number of events 6 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
fever
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
flu-like symptoms
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
gastritis
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
GI bleed/bloody diarrhea/rectal bleed
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
H/A
|
50.0%
5/10 • Number of events 5 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
hematuria
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Hot flashes
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Hyperpigmentation
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
hyperglycemia
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Hypoalbumin
|
40.0%
4/10 • Number of events 4 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Hypocalcemia
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
hypohydrosis
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
HypoK
|
50.0%
5/10 • Number of events 5 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
HypoMG
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Hyponatremia
|
80.0%
8/10 • Number of events 8 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
hypotension
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Hypertension
|
50.0%
5/10 • Number of events 5 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
INR
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Lightheadedness
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
lymphocyte decrease
|
70.0%
7/10 • Number of events 7 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
migraine
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
mucositis/mouth sores
|
80.0%
8/10 • Number of events 8 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
myalgia
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
arthralgia
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
nausea
|
70.0%
7/10 • Number of events 7 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain-abdomen
|
40.0%
4/10 • Number of events 4 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain/back and neck
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain secondary to abcess/infection
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain-epigastric
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain-general
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain-joints
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
pain-leg
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
rectal pain/perianal pain
|
50.0%
5/10 • Number of events 5 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
paresthesia
|
20.0%
2/10 • Number of events 2 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
PLT
|
50.0%
5/10 • Number of events 5 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Radiation Dermatitis
|
40.0%
4/10 • Number of events 4 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
rash
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
skin ulceration/Groin sore
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
infection (cellulitis/small intestine, abscess, UTI, vaginal)
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
social circumstances
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
sore throat
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
Tachycardia
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
tooth infection
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
urinary frequency
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
urinary pain/dysuria
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
urinary retention
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
vomitng
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
WBC
|
60.0%
6/10 • Number of events 6 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
weakness
|
10.0%
1/10 • Number of events 1 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
|
Investigations
wt loss
|
30.0%
3/10 • Number of events 3 • SAEs and AEs are captured from the time of consent until 30 days post the last treatment. SAEs occurring post 30 days are required to be reported if they are potentially related.
Please note that all SAEs and AEs that occurred and were reported are noted in this database, but that does not mean that the SAEs or AEs reported here in the results table are related to the study drug ADXS11-001 or the combination. In short, these are SAEs or AEs that occurred, but the reporting of them here, does not equate to a relationship to study treatment. The SAEs include multiple events but this represents the actual SAE as reported by the site and as reported to NIH OBA and the FDA.
|
Additional Information
Howard Safran, MD
Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place