Trial Outcomes & Findings for QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (NCT NCT03387085)
NCT ID: NCT03387085
Last Updated: 2024-08-09
Results Overview
Graded using the NCI CTCAE Version 4.03.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-08-09
Participant Flow
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study. Eligible participants could have gone through both induction and maintenance treatment on study.
Participant milestones
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
A combination of agents was planned to be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
A combination of agents was planned to be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Overall Study
Reason for Treatment Discontinuation
|
7
|
Baseline Characteristics
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
Baseline characteristics by cohort
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 6.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
subjects with TNBC who have progressed on or after previous SoC chemother
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsGraded using the NCI CTCAE Version 4.03.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment emergent adverse events
|
9 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment emergent Serious Adverse Events
|
5 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression. Up to 2.5 yearsTumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Percent of subjects with confirmed complete Response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Objective Response Rate by RECIST v1.1
|
5 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression. Up to 2.5 years.Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with Response Evaluation Criteria in Solid Tumors (irRC) Version 1.1. Percent of subjects with confirmed complete Response or partial response by irRC.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Objective Response Rate by irRC (Percent of Subjects With Confirmed Complete or Partial Overall Response)
|
6 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first. Up to 2.5 years.PFS were defined as the time from the date of first treatment to the date of disease progression or death (any cause), whichever occured first. Subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Progression Free Survival by RECIST v1.1
|
13.7 months
Interval 2.2 to
Due to the small number of subjects an upper bound on the confidence interval was not able to be calculated
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.PFS were defined as the time from the date of first treatment to the date of disease progression or death (any cause), whichever occured first. Subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Progression Free Survival by irRC
|
14.3 months
Interval 2.2 to
Due to the small number of subjects an upper bound on the confidence interval was not able to be calculated
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.DOR were evaluated using Kaplan-Meier methods for those subjects with a confirmed response. DOR were defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occured first. Responding subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in DOR analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=5 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Duration of Response by RECIST Version 1.1
|
11.4 months
Interval 4.9 to
Due to the small number of subjects an upper bound on the confidence interval was not able to be calculated
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression. Up to 2.5 years.Disease control was defined as subjects with a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting for at least 2 months. Complete response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) or stable disease (SD; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD)
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Disease Control Rate by RECIST Version 1.1
CR
|
2 Participants
|
|
Disease Control Rate by RECIST Version 1.1
PR
|
3 Participants
|
|
Disease Control Rate by RECIST Version 1.1
SD greater than or equal to 2 months
|
2 Participants
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.DOR were evaluated using Kaplan-Meier methods for those subjects with a confirmed response. DOR were defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occured first. Responding subjects completing study follow-up or starting a new anticancer therapy prior to documented PD were censored in DOR analysis at the last known date the subject was progression free prior to completing follow-up or initiating new therapy.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=6 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Duration of Response by irRC
|
11.4 months
Interval 4.3 to
Due to the small number of subjects an upper bound on the confidence interval was not able to be calculated
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first. Up to 2.5 years.Disease control was defined as subjects with a confirmed Complete Response (irCR), Partial Response (irPR), or Stable Disease (irSD) lasting for at least 2 months. Complete response (irCR; disappearance of all index lesions) or partial response (irPR; \>=100% decrease in the sum of the longest diameter of index lesions with stable non-index lesions or \>=50% decrease in the sum of index lesions with absent/stable /progressed non-index lesions) or stable disease (irSD; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD)
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Disease Control Rate by irRC
irSD greater than or equal to 2 months
|
2 Participants
|
|
Disease Control Rate by irRC
irCR
|
1 Participants
|
|
Disease Control Rate by irRC
irPR
|
5 Participants
|
SECONDARY outcome
Timeframe: Evaluated from screening to death.OS were evaluated using Kaplan-Meier methods. OS were defined as the time from the date of first treatment to the date of death (any cause). Subjects who are alive at the end of follow-up were censored in the OS analysis at the last known date alive.
Outcome measures
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 Participants
A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Overall Survival
|
20.2 months
Interval 2.4 to 45.2
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsPopulation: Due to low enrollment, Quality of Life by Patient Reported Outcomes was not summarized. 0 overall number of participants were analyzed. Data not collected.
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) instrument on study
Outcome measures
Outcome data not reported
Adverse Events
NANT Triple Negative Breast Cancer (TNBC) Vaccine
Serious events: 5 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 participants at risk
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
General disorders
Disease progression
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Injection site reaction
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Pyrexia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Mastitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
Other adverse events
| Measure |
NANT Triple Negative Breast Cancer (TNBC) Vaccine
n=9 participants at risk
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
9/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
77.8%
7/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Toothache
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Anal inflammation
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Cheilitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Lip erythema
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Lip swelling
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Lip ulceration
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Fatigue
|
100.0%
9/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Pyrexia
|
100.0%
9/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Injection site reaction
|
88.9%
8/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Mucosal inflammation
|
88.9%
8/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Chills
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Chest discomfort
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Axillary pain
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Chest pain
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Influenza like illness
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Injection site erythema
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Catheter site erythema
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Catheter site pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Disease progression
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Feeling cold
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Injection site pruritus
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Swelling
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
Xerosis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
9/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Injury, poisoning and procedural complications
Overdose
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Injury, poisoning and procedural complications
Tracheal deviation
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Injury, poisoning and procedural complications
Wound
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Headache
|
66.7%
6/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Paraesthesia
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Dysgeusia
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Burning sensation
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Horner's syndrome
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Neurological symptom
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Nervous system disorders
Vocal cord paralysis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
77.8%
7/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.6%
5/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Papule
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
88.9%
8/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
6/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
6/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
55.6%
5/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Catheter site cellulitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Herpes simplex
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Implant site infection
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Mastitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Skin candida
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Tooth infection
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Infections and infestations
Vulval abscess
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Investigations
Weight decreased
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Investigations
Weight increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
55.6%
5/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Psychiatric disorders
Depression
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Psychiatric disorders
Nightmare
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Psychiatric disorders
Irritability
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Vascular disorders
Deep vein thrombosis
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Surgical and medical procedures
Hypotension
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Vascular disorders
Lymphoedema
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Ear and labyrinth disorders
Vertigo
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Endocrine disorders
Hypothyroidism
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Eye disorders
Eye disorder
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Eye disorders
Photophobia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Renal and urinary disorders
Pollakiuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Renal and urinary disorders
Hepatobiliary disorders
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Renal and urinary disorders
Cholecystitis
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Immune system disorders
Seasonal allergy
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
Product Issues
Device occlusion
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
|
General disorders
RED AND PUFFY LIPS
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer up to 2.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place